Studienangebot der Klinik für Neurologie

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Refik Pul

refik.pul@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Westfälische Wilhelms-Universität Münster

Indikation
MS – Multiple Sklerose

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Refik Pul

refik.pul@uk-essen.de

Hufelandstr 55
45147 Essen

Einschlusskriterien
schriftliches Einverständniserklärung für die Teilnahme am Register, nach erfolgter Aufklärung, sichere MS mit bestimmbarerer Verlaufsform oder KIS, primärer Wohnsitz in Deutschland

Ausschlusskriterien
Nicht bestimmbare MS-Verlaufsform, fehlende Einwilligungserklärung

Indikation
MS – Multiple Sklerose

Institute
Klinik für Neurologie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

German Cancer Research Center, Heidelberg

Einschlusskriterien
– Age ≥ 18 years, smoking or non-smoking, of any ethnic origin and gender
– Patients present with unequivocal first, second or third recurrence of a histologically confirmed IDH1R132H-mutated glioma WHO grade II, III or IV progressive after radiotherapy and chemotherapy
– Absence of chromosomal 1p/19q co-deletion in the primary tumor tissue and/or
– Loss of nuclear ATRX expression in the primary tumor tissue (partial loss allowed)
– Availability of tumor tissue for analysis (FFPE bulk tissue)
– Patients have received radiotherapy (54 – 60 Gy) and at least six months of alkylating chemotherapy
– Patients are at least three months off radiotherapy
– Patients must be candidates for re-resection and the re-resection must be postponable for seven weeks
– Patients should be immunocompetent (i.e. no concomitant treatment with dexamethasone (or equivalent), or receive stable/decreasing steroid levels not exceeding 2 mg/day dexamethasone (or equivalent) during the last 3 days prior to clinical screening; no severe lymphopenia)
– Karnofsky Performance Status ≥ 70
– Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
– Ability of patient to understand character and individual consequences of the clinical trial
– Evidence of informed consent document personally signed and dated by the patient (or a witness in case the patient is unable to write) and indicating that the patient has been informed of all pertinent aspects of the study and that the patient consents to participate in the trial
– Women of child-bearing potential (WOCBP; i.e. those who have not undergone a hysterectomy, bilateral salpingectomy and bilateral oophorectomy or who have not been post-menopausal for at least 24 consecutive months) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of the investigational medicinal product(s) (IMPs).
– WOCBP must be using an effective method of birth control to avoid pregnancy throughout the study and for 3 months after the last dose of the IMP. This includes two different forms of effective contraception (e.g. hormonal contraceptive and condom, IUD/IUS and condom) or sterilization, resulting in a failure rate less than 1% per year.
– Men must be willing and able to use an effective method of birth control throughout the study for up to 3 months after the last dose of the IMP(s), if their sexual partners are WOCBP (acceptable methods see above).
– Availability of pre-study MRT (magnetic resonance tomography) of latest tumor recurrence
– Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Ausschlusskriterien
– Current use of immunosuppressive medication, EXCEPT for the following:
1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
2. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent;
3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
– Pregnancy or lactation
– Previous or concurrent experimental treatment for the tumor other than radiotherapy and alkylating chemotherapy. This includes local therapies such as interstitial radiotherapy or local chemotherapy (i.e. BCNU wafers), loco-regional hyperthermia, electric fields, and antiangiogenic therapy (such as Bevacizumab).
– Abnormal (= Grade 2 CTCAE v4.03) laboratory values for thyroid gland: free T4 and TSH
– Abnormal (= Grade 2 CTCAE v4.03) laboratory values for hematology, liver and renal function (serum creatinine). In detail, the following values apply as exclusion criteria:
1. Hemoglobin < 9 g/dL (5.59 mmol/L)
2. White blood cell count (WBC) decrease ( 10.0 x 109/L)
3. Absolute neutrophil count (ANC) decrease (< 1.5 x 109/L)
4. Platelet count decrease (< 100 x 109/L)
5. Bilirubin > 1.5 x ULN (upper limit of normal according to the performing lab´s reference range)
6. ALT > 2,5 x ULN
7. AST > 2,5 x ULN
8. GGT > 2.5 x ULN
9. Serum creatinine increase (> 1.5 x ULN)
– Patients with history or presence of HIV and/or HBV/HCV positivity (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
– Patients with history or known presence of tuberculosis (positive QuantiFERON®-TB Gold test (or equivalent) or tuberculin skin test). Patients with an indeterminate result of the QuantiFERON®-TB Gold test (or equivalent) are not eligible unless additional testing demonstrates a negative result (tuberculin skin test or repeated QuantiFERON®-TB Gold test/or equivalent). If a tuberculin skin test is performed, an induration of > 6 mm is “positive” for a patient with history of BCG vaccine, while an induration of > 10 mm is “positive” for a patient without history of BCG vaccine. If necessary, a QuantiFERON®-TB Gold or equivalent test might be complemented by additional specific diagnostic tests as per standard procedures.
– Patients with severe infection(s) or signs/symptoms of infection within 2 weeks prior to the first administration of the study drug(s)
– Active infection requiring systemic therapy
– Patients who have received a live, attenuated vaccine within 4 weeks prior to the first administration of the study drug(s)
– Patients with a prior solid organ transplantation or haematopoietic stem cell transplantation
– Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
– Clinically significant (i.e., active) cardiovascular disease: Cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
– Persisting toxicity related to prior therapy (NCI CTCAE v.4.03 Grade >1); however, alopecia, sensory neuropathy Grade = 2, or other persisting toxicities Grade = 2 not constituting a safety risk based on investigator´s judgement is acceptable.
– Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
– History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade = 3).
– Participation in other clinical trials or their observation period during the last 30 days before the first administration of the IMP(s).

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
NONKO – Neuroonkostudien

Medizinischer Befund
Malignant Glioma

Institute
Klinik und Poliklinik für Strahlentherapie, Klinik für Neurologie, Westdeutsches Protonentherapiezentrum (WPE), Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Universitätsklinik Essen (AöR)

+49 (0)201 723-0
info@uk-essen.de

Hufelandstraße 55
45147 Essen

Einschlusskriterien
• Histologisch gesichertes WHO Grad II oder III Gliom mit Indikation zur Durchführung einer Strahlentherapie nach Beschluss der lokalen neuroonkologischen Konferenz des Studienzentrums
• Klassifikation des Tumors gemäß der WHO-Klassifikation 2016 inkl.: mutierter IDH-Status muss nachgewiesen sein, Bestimmung des 1p/19q Deletionsstatus und MGMT- Promotormethylierungsstatus muss vorliegen
• Ein Karnofsky-Index von ≥ 70%
• Patienten müssen ≥ 18 Jahre sein
• Beginn der Strahlentherapie innerhalb 6 Wochen nach Operation
• Zum Zeitpunkt des Studieneinschlusses sollte der Abstand zur letzten Operation ≥ 2 Wochen sein. Die Patienten müssen sich von den Folgen der Operation erholt haben
• Patient muss zustimmen und in der Lage sein eine neurokognitive Baseline-Testung noch vor Gabe der ersten Strahlendosis durchzuführen
• Der Patient muss vor Studieneinschluss die schriftliche Einwilligung zur Studienteilnahme erteilen
• Studienpatient ist in der Lage Sinn und Tragweite der Studie zu verstehen und ist gewillt den Anweisungen der klinischen Studie zu folgen und aller Voraussicht nach die geplanten Studienvisiten einzuhalten.
• Gebährfähige Patientinnen müssen einen negativen Schwangerschaftstest (aus dem Serum oder Urin) aufweisen, der nicht älter als 7 Tage ist zum Zeitpunkt der ersten Studienintervention.
• Laborwerte nicht älter als 3 Wochen vor Studieneinschluss: Absolutwert neutrophiler Granulozyten ≥ 1500/mm³, Thrombozytenzahl ≥ 100 000/mm³, Hämoglobinwert (Hb) >10 g/dL, Gesamtbilirubinwert ≤ 1,5-fach der oberen Normwertgrenze, Werte für Aspartat-Aminotransferase (AST) und Alanin-Aminotransferase (ALT) ≤ 3-fach der oberen Normwertgrenze, Kreatininwert ≤ 1,5-fach der oberen Normwertgrenze

Ausschlusskriterien
• Gleichzeitige Teilnahme an einer anderen klinischen Studie oder Teilnahme an einer klinischen Studie, die die Gabe eines Prüfpräparats innerhalb von 30 Tagen vor Studieneinschluss erfordert.
• Physischer oder psychischer Zustand des Patienten, der, im Ermessen des Studienarzts, den Patienten gefährden könnte, die Studienergebnisse verfälschen könnte oder der die Teilnahme des Patienten an der klinischen Studie negativ beeinflussen könnte.
• Bekannter oder anhaltender Missbrauch von Drogen, Alkohol oder Medikamenten.

Indikationsspezifische Ausschlusskriterien:
• Vorausgegangene Strahlentherapie am Kopf oder im Gesichts-Halsbereich
• Vorausgegangene Chemotherapie aufgrund einer ZNS Neoplasie
• Schwere Komorbidtät, die eine Compliance mit den Studienvorgaben limitiert
• Bösartige invasive Tumorerkrankung mit einer Tumorfreiheit von < 3 Jahren
• Hinweise für eine leptomeningeale Dissiminierung
• Spinale oder infratentorielle Tumorlokalisation
• Patienten mit bekannter Infektion mit dem humanen Immundefizienz-Virus (HIV) und unter laufender retroviraler Therapie.
• Patienten mit neuerlich diagnostizierter Hepatitis-Infektion oder – nach Ermessen des zuständigen Studienarztes – erheblichem Risiko einer Reaktivierung

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
NONKO – Neuroonkostudien

Medizinischer Befund
Gliom

Institute
Klinik und Poliklinik für Strahlentherapie, Klinik für Neurologie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

NOXXON Pharma AG, Berlin

Einschlusskriterien
1. Written informed consent
2. Age ≥18 years
3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy
4. Patient agrees to subcutaneous port implantation
5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
6. Status post biopsy or incomplete resection
7. Unmethylated MGMT promoter status
8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
9. Estimated minimum life expectancy 3 months
10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
11. The following laboratory parameters should be within the ranges specified:
– Total bilirubin ≤ 1.5 x upper limit normal (ULN)
– Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
– ALT (alanine transaminase) ≤ 3 x ULN
– AST (aspartate transaminase) ≤ 3 x ULN
12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence)” during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
13. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP

Ausschlusskriterien
1. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
3. Contra-indication or known hypersensitivity to MRI contrast agents, olaptesed pegol or polyethylene glycol
4. Cytostatic therapy (chemotherapy) within the past 5 years
5. History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
6. Clinically significant or uncontrolled cardiovascular disease
7. Prior radiotherapy to the head
8. Any other previous or concomitant experimental glioblastoma treatments
9. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
10. Pregnancy or lactation
11. Uncontrolled intercurrent illness; patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator’s opinion, interfere with the conduct of the study or study evaluations
12. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
13. Prior enrolment into this study

Exclusion Criteria Expansion Group Arms A and B:
1. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
3. Contra-indication or known hypersensitivity to MRI contrast agents, bevacizumab (Arm A only) olaptesed pegol or polyethylene glycol
4. Planned hypofractionated radiotherapy
5. Cytostatic therapy (chemotherapy) within the past 5 years
6. History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
7. Secondary malignancy which is currently active
8. Clinically significant or uncontrolled cardiovascular disease, including
– Myocardial infarction in the previous 12 months
– Uncontrolled angina
– Congestive heart failure (New York Heart Association functional classification of =2)
– Diagnosed or suspected congenital long QT syndrome
– QTc prolongation on an electrocardiogram prior to entry (>470 ms)
– Uncontrolled hypertension (blood pressure = 160/95 mmHg)
– Heart rate <50/min on the baseline electrocardiogram
– History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
– Cerebrovascular accident
9. Prior radiotherapy to the head
10. Any other previous or concomitant experimental glioblastoma treatments
11. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
12. Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants (Arm A only)
13. Pregnancy or lactation
14. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator’s opinion, interfere with the conduct of the study or study evaluations
15. Prolongation of coagulation factors = 2.5 x ULN (Arm A only)
16. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
17. Prior enrolment into this study

Exclusion Criteria Expansion Group Arms C:
1. Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies
3. Contra-indication or known hypersensitivity to MRI contrast agents olaptesed pegol or polyethylene glycol or pembrolizumab (= Grade 3)
4. Biopsy-only of GBM with less than 20% of tumor removed
5. Presence of extracranial metastatic or leptomeningeal disease
6. Severe hypersensitivity (= Grade 3) to other monoclonal antibodies
7. Receiving immunosuppressive therapy
8. Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent
9. Planned hypofractionated radiotherapy
10. Cytostatic therapy (chemotherapy) within the past 5 years
11. History of other cancers or secondary malignancy which is currently active (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
12. Clinically significant or uncontrolled cardiovascular disease, including
– Myocardial infarction in the previous 12 months
– Uncontrolled angina
– Congestive heart failure (New York Heart Association functional classification of =2)
– Diagnosed or suspected congenital long QT syndrome
– QTc prolongation on an electrocardiogram prior to entry (>470 ms)
– Uncontrolled hypertension (blood pressure = 160/95 mmHg)
– Heart rate <50/min on the baseline electrocardiogram
– History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
– Cerebrovascular accident
13. Prior radiotherapy to the head
14. Evidence of acute intracranial / intra-tumoral hemorrhage
15. Any other previous or concomitant experimental glioblastoma treatments
16. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
17. Pregnancy or lactation
18. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator’s opinion, interfere with the conduct of the study or study evaluations.
19. Received a live vaccine within 30 days prior to the first dose of study drug.
20. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may participate provided these remain stable
21. Known history of HIV infection, hepatitis B or hepatitis C infection
22. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
23. History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
24. Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
25. High dose of corticosteroids (> 4mg/day of dexamethasone or equivalent for at least 3 consecutive days) within two weeks prior to the first dose of study drug
26. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
27. Prior enrolment into this study

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
Glioblastom

Medizinischer Befund
Glioblastom

MedDRA Term
Glioblastoma

Institute
Klinik für Gastroenterologie und Hepatologie, Klinik für Neurologie, LVR Kliniken-Essen – Klinik für Psychosomatische Medizin und Psychotherapie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Eva-Maria Skoda

+49 (0)201 438755-226
Eva-maria.skoda@lvr.de

Virchowstraße 174
45147 Essen

Indikation
Diverse

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Köhrmann

martin.koehrmann@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Hamilton Health Sciences Corporation, Kanada

Einschlusskriterien
1. Written informed consent provided
2. Age ≥45 years, at the time of signing the informed consent
3. Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic non-lobar intraparenchymal or intraventricular hemorrhage, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy
4. Documented atrial fibrillation (paroxysmal, persistent, permanent)
5. CHA2DS2-VASc score ≥2

Ausschlusskriterien
1. Recent intracranial hemorrhage (within 14 days)
2. Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
3. Isolated subarachnoid hemorrhage (convexity or basal); subarachnoid blood tracking onto convexity secondary to an intraventricular hemorrhage or as part of a multicompartment bleed in cases of traumatic subdural hemorrhages are eligible
4. Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
5. Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
6. Plans for left atrial appendage occlusion
7. Estimated creatinine clearance (CrCl) < 15 mL/min
8. Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
9.Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
10. Chronic use of NSAID
11. Clinically significant active bleeding, including gastrointestinal bleeding
12. Lesions or conditions at increased risk of clinically significant bleeding, e.g. active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis
13. Antiphospholipid antibody syndrome
14. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
15. Known hypersensitivity to edoxaban
16. Estimated inability to adhere to study procedures
17. Pregnancy or breastfeeding
18. Estimated life expectancy < 6 months at the time of enrollment
19. Close affiliation with the investigational site; e.g. a close relative for the investigator, dependent person (e.g., employee or student of the investigational site)
20. Lobar intraparenchymal hemorrhage
– Post menopausal female subjects must be amenorrheic for =12 months prior to screening or =6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to screening. Women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization or urine pregnancy testing within 24 hours of randomization. Heterosexually active women of childbearing potential must use highly effective methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).

Studienteilnehmende Mindestalter
45 Jahr(e)

Indikation
STROKE  – Schlaganfall

Medizinischer Befund
Intracranial Hemorrhages\nAtrial Fibrillation

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Refik Pul

refik.pul@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Genzyme Corporation, USA

Binney Street 50
02142 Cambridge

Einschlusskriterien
– 18 to 55 years of age inclusive
– Diagnosis of PPMS according to the 2017 McDonald criteria
– Expanded disability status scale (EDSS) score between 2.0 to 6.5 points, at screening inclusive
– Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
– Contraceptive use consistent with local regulations for individuals participating in clinical studies
Participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies:
– Is not a woman of child bearing potential (WOCBP)
OR
– Is a WOCBP and agrees to use an acceptable contraceptive method

Ausschlusskriterien
– Participant has conditions that would adversely affect study participation such as short life expectancy.
– History of organ transplant.
– Evidence of infection with human immunodeficiency virus (HIV), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
– History of malignancy within 5 years prior to screening.
– History of alchohol or drug abuse within 1 year prior to Screening.
– Hospitalized for psychiatric disease within 2 years prior to Screening.
– Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
– Bleeding disorder, known platelet dysfunction or platelet count <150 000/µL at Screening or history of significant bleeding event within 6 months prior to Screening.
– Lymphocyte count below the lower limit of normal at Screening.
– Recent live (attenuated) vaccine within 2 months before the first treatment visit.
– Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
– The participant has received medications/treatments for MS within a specified time frame.
– Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
– Receiving anticoagulant or antiplatelet therapy (such as aspirin, clopidogrel, warfarin).
– Contraindications to magnetic resonance imaging (MRI).
NOTE: Other Inclusion/Exclusion criteria may apply

Studienteilnehmende Mindestalter
18 Jahr(e)

Studienteilnehmende Höchstalter
55 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
MS – Multiple Sklerose

Medizinischer Befund
Primary Progressive Multiple Sclerosis

MedDRA Term
Primary progressive multiple sclerosis

Institute
Klinik für Neurologie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Novocure GmbH

Einschlusskriterien
1. Histologically confirmed diagnosis of GBM according to WHO classification criteria.
2. Age ≥ 18 years
3. Recovered from maximal debulking surgery, if applicable (gross total resection, partial
resection and biopsy-only patients are all acceptable)
4. Planned treatment with RT/TMZ followed by TTFields and maintenance TMZ (150-200
mg/m2 daily x 5 d, q28 days)
5. Karnofsky performance status ≥ 70
6. Life expectancy ≥ least 3 months
7. Participants of childbearing age must use highly effective contraception. An effective method
of birth control is defined as one that results in a failure rate of less than 1% per year when
used consistently and correctly. The Investigator must approve the selected method, and
may consult with a gynecologist as needed.
8. All patients must understand and voluntarily sign an informed consent document prior to any
study related assessments/procedures being conducted.
9. Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if
applicable.
10. Concomitant RT with TMZ treatment planned to start no later than 8 weeks from surgery
11. Women of childbearing potential must have a negative β-HCG pregnancy test documented
within 14 days prior to registration
12. Is able to have MRI with contrast of the brain

Ausschlusskriterien
1. Progressive disease (per investigator’s assessment)
2. Infratentorial or leptomeningeal disease
3. Participation in another clinical treatment study during the pre-treatment and/or the treatment
phase of the study
4. Pregnancy or breast-feeding.
5. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ
treatment, as determined by the investigator:
a. Thrombocytopenia (platelet count < 100 x 103/µL)
b. Neutropenia (absolute neutrophil count < 1.5 x 103/µL)
c. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
d. Significant liver function impairment – AST or ALT > 3 times the upper limit of normal
e. Total bilirubin > 1.5 x upper limit of normal
f. Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l)
g. History of any psychiatric condition that might impair patient’s ability to understand or
comply with the requirements of the study or to provide consent
6. Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices
in the brain, or documented clinically significant arrhythmias.
7. Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant
papilledema, vomiting and nausea or reduced level of consciousness)
8. History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.
9. Any other cytotoxic or biologic anti-tumor therapy received prior to enrollment will be
considered exclusion.
10. Admitted to an institution by administrative or court order.
11. Known allergies to medical adhesives or hydrogel
12. A skull defect (such as, missing bone with no replacement)
13. Prior radiation treatment to the brain for the treatment of GBM
14. Any serious surgical/post-operative condition that may risk the patient according to the
investigator
15. Standard TTFields exclusion criteria include
a. Active implanted medical devices
b. Bullet fragments
c. Skull defects

Studienteilnehmende Mindestalter
18 Jahr(e)

Indikation
Glioblastom

Medizinischer Befund
Glioblastom

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dirk Hermann

dirk.hermann@uk-essen.de

Hufelandstr 55
45147 Essen

Einschlusskriterien
Erwachsene Patienten mit erstmaligem akutem (bis 48 Stunden nach Symptombeginn) ischämischem Schlaganfall

Ausschlusskriterien
– Vorherige Infarkte
– subakute oder chronische Infarkte (>48 Stunden nach Symptombeginn)
– hämorrhagische Infarkte
– nicht erfolgte Einwilligung

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Divers, Männlich, Weiblich

Indikation
STROKE  – Schlaganfall

Medizinischer Befund
ischemic stroke

Institute
Klinik für Neurologie, Klinik für Kinderheilkunde II, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

European Organisation for Research and Treatment of Cancer (EORTC), Belgien

Einschlusskriterien
• Newly diagnosed, histologically proven, genetically classified, centrally confirmed medulloblastoma (WNT M0-1, SHH (p53wt) M0-1, Group 4 M0-1)
• Molecular subtype: medulloblastoma, SHH-activated and TP53-wildtype, M0-1; medulloblastoma, WNT-activated, M0-1; medulloblastoma, Group 4, M0-1
• Histologic subtype: medulloblastoma, classic (CMB); medulloblastoma, desmoplastic/nodular (DNMB); medulloblastoma, with extensive nodularity (MBEN); medulloblastoma, large cell/anaplastic (LCA)
• Adults (≥ 18 years) in WNT-activated and Group 4 medulloblastoma
• Post-pubertal patients (<18y of age), or adults (18 y of age and above) in SHH-activated and TP53-wildtype medulloblastoma
Non-SHH dependent patients under age 18 should be transferred to a paediatric site for inclusion in the PNET5 trial in countries where PNET5 is open. SHH-activated patients under age 18 with M1 disease or above should be transferred to a paediatric site for inclusion in the HRMB trial in countries where HRMB is open.
• For patients with SHH activated tumours: exclusion of germline alteration of TP53, PTCH, SUFU, BRCA2 and PALB2 if known before randomization or enrollment
• Clinical status within 2 weeks of randomization/enrollment: Karnofsky 50-100. NANO-score 0 to 9 (allowing full-blown cerebellar symptoms)
• Clinically standard-risk (centrally assessed MRI review) defined as: total or near total surgical resection with less than or equal to 1.5 cm2 (measured in axial plane) of residual tumour on early post-operative MRI, without and with contrast; no CNS metastasis on MRI (cranial and spinal); Chang stage M0-1 with no clinical evidence of extra-CNS metastasis
• Full recovery from surgery or any post-surgical complication (e.g. bleeding, infections etc.)
• Post-surgery (within 72h) MRI available (pre-surgery MRI upload is encouraged if available)
• Baseline brain MRI and spinal MRI for uploading available within 2 weeks of randomization/enrollment
• Normal liver, renal and haematological function within 2 weeks of randomization/enrollment.
• WBC ≥ 3×10^9/L
• ANC ≥ 1.5×10^9/L
• Platelet count of ≥ 100×10^9/L independent of transfusion
• Hemoglobin ≥ 10 g/dl
• Total Bilirubin ≤ 1.5 × ULN
• ALT (SGPT), AST (SGOT), alkaline phosphatase (ALP) ≤ 2.5 × ULN
• Serum creatinine 30 mL/min (using the Cockcroft-Gault formula)
• Negative serum or urine pregnancy test within 7 days before randomization/enrollment for WOCBP
• Patients of childbearing / reproductive potential (WOCBP) must use two methods of adequate birth control, including a highly effective method and a barrier method during the study treatment period and for at least 20 months after the last study treatment is mandatory for the patients that received sonidegib, for all other patients this period is at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Male patients even those who have had a vasectomy must always use a condom during treatment and for 6 months after last treatment. Men should not donate semen during treatment and for at least 6 months after ending treatment (donation of semen for the semen analyses in the 1 b fertility project is allowed)
• Female subjects who are breast feeding must discontinue nursing prior to the first dose of study treatment and until 20 months after the last study treatment
• Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. For patients less than 18 years of age, consent has to be obtained from the parent(s) or legal representative.

Ausschlusskriterien
• Prior treatment for medulloblastoma
• Unavailability of central review pathology results
• Known prognostic markers (MYC/MYCN amplification, MYC/MYCN mutation)
• Inability to start radiotherapy within 43 days after surgery
• Significant sensorineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing impairment = 20 dB at 1-3 kHz
• Any medical contraindication to radiotherapy or chemotherapy
• Hypersensitivity to contrast medium for MRI
• Hypersensitivity towards the active substance of any of study drugs or their excipients
• Prior or current use of mitoxantrone, methotrexate, topotecan, imatinib, irinotecan or statins
• Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, psychiatric disorder) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
• Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical carcinoma in situ, low risk prostate cancer (cT1-2a N0 and Gleason score = 6 and PSA < 10 ng/mL), either totally resected or irradiated with curative intent (with PSA of less than or equal to 0.1 ng/mL) or under active surveillance as per ESMO guidelines. Other cancers for which the subject has completed potentially curative treatment more than 5 years prior to diagnosis of medulloblastoma study entry are allowed
• Known history or current evidence of active Hepatitis B (e.g., positive HBV surface antigen) or C (e.g., HCV RNA [qualitative] is detected)
• Known or current evidence of Human Immunodeficiency Virus (HIV) infection (positive HIV-1/2 antibodies)
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
NONKO – Neuroonkostudien

Medizinischer Befund
Newly Diagnosed Medulloblastoma

MedDRA Term
Medulloblastoma

Institute
Klinik für Neurologie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

PD Dr. med. Sied Kebir

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Novocure GmbH

Einschlusskriterien
– ≥ 18 years of age
– Newly diagnosed, histologically confirmed GBM (WHO Grade IV)
– Patient after completion of radiochemotherapy but within first 3 cycles of first-line tumor-specific mainte-nance chemotherapy
– Clinical indication of treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines
– Signed informed consent

Ausschlusskriterien
– Any foreseeable deviation from the IFU of NovoTTF-200A System (Optune®)

Indikation
Glioblastom

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Refik Pul

refik.pul@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Merck KGaA

+49 (0)6151 720
service@merckgroup.com

Frankfurter Straße 250
64293 Darmstadt

Einschlusskriterien
– Patienten müssen neu mit der Behandlung mit Cladribin oder Fingolimod beginnen.
– Patienten müssen eine schriftliche Einwilligungserklärung abgeben (in Ländern, in denen sowohl retrospektive als auch prospektive Daten gesammelt werden und in einigen Ländern in denen nur sekundäre Daten gesammelt werden.)

Ausschlusskriterien
– Einnahme von Fingolimod, bevor mit der Behandlung mit oralem Cladribin angefangen wird.
– Einnahme von oralem Cladribin, bevor mit der Einnahme von Fingolimod angefangen wird.

Studienteilnehmende Mindestalter
18 Jahr(e)

Studienteilnehmende Höchstalter
99 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
MS – Multiple Sklerose

Medizinischer Befund
Multiple Sklerose (MS)

Institute
Klinik für Neurologie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Rheinische Friedrich-Wilhelms-Universität Bonn

Einschlusskriterien
1. First relapse after first-line therapy with radiotherapy (RT) and alkylating chemotherapy, > 3 months after last chemotherapy application and >6 months after end of RT. Drug therapy and/or radiothera-py for first relapse treatment not yet started.
2. Tumor progression according to RANO criteria
3. Written informed consent
4. Cognitive state to understand rationale and necessity of study therapy and procedures
5. MGMT promotor-methylated (MGMTmeth), IDH wildtype glioblastoma (GBM) or gliosarcoma con-firmed with histology of the primary resection
6. age > 18 years
7. Karnofsky performance score (KPS) ≥60%;
8. Life expectancy > 6 months
9. Adequate bone marrow reserve (WBC >3 G/nl, platelets >100 G/nl)
10. Adequate liver function (bilirubin <1.5 x ULN; ASAT /ALAT <3 x ULN, creatinine < 1.5 x ULN)
11. Patient compliance and geographic proximity that allow adequate follow up
12. Male and female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the trial (Pearl index <1%)
13. Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test (beta-HCG) must be obtained prior to treatment start
Additional inclusion criterion ONLY for phase I:
14. Resection at first relapse not yet performed; according to the local treating neurosurgeon and the documented decision of local neurooncological tumor board, reresection of the tumor is clinically indicated and can be safely de-ferred until day 7-10 after initiation of MFA/TMZ therapy.

Ausschlusskriterien
1. Indication for hematotoxicity in first-line therapy not allowing TMZ starting dose 150 mg/m2/d
2. Skin or liver toxicity >CTCAE5 grade 1 in first-line therapy
3. History of gastrointestinal bleeding or gastroduodenal ulcer, active gastritis
4. History of asthma, urticaria or allergic-type skin reactions to NSAID
5. Prior malignancy other than glioma
6. History of confirmed or suspected hypersensitivity (delayed type and immediate type, inclusive of anaphylactic reaction) to any background/ standard TMZ drug product or one of its ingredients of the chosen product, or to cyclooxygenase inhibitors (“NSAIDs”), or to any ingredient of meclofenamate drug product
7. History of disease with poor prognosis
8. Severe coronary heart disease (esp. after coronary artery bypass graft or history of myocardial infarction), severe heart failure
9. Known HIV infection, active hepatitis B or C
10. Breastfeeding or pregnant
11. Unable to undergo contrast-enhanced MRI (i.e. contrast allergy, implants, etc).
12. Treatment in another clinical trial with therapeutic medical intervention or use of any other investiga-tional agent during the trial or within the 30 days before enrollment
13. Medication with a drug that is not allowed in conjunction with MFA intake and cannot be discontin-ued: i.e. lithium, methotrexate, etc.
14. Patients with active bleeding, bleeding diathesis, antiplatelet therapy or anticoagulant therapy except for the following anticoagulants which are permitted for low-dose thrombosis prophylaxis up to the dosage specified here: unfractionated heparin 7,500 IU BID or 5,000 IU TID; low molecular weight heparin e. g. enoxa-parin 40 mg/d; fondaparinux 2.5 mg/d; danaparoid sodium 750 IU BID; argatroban IV route throm-bin time < 70 s; vitamin-K-antagonist INR < 1.8; dabigatran 150 mg BID; rivaroxaban 10 mg/d; edoxaban 30 mg/d; epixaban 2.5 mg BID This restriction is due to a potentially increased risk of GI ulcers with subsequent bleeding under MFA therapy
15. Patients with medically diagnosed hereditary Galactose Intolerance, complete lactase deficiency or confirmed Glucose-Galactose-Malabsortion
16. Medical History of gastrointestinal Resection of any kind that may potentially alter the absorption of the investigational study drug, according to investigators judgement
17. The presence of any other concomitant severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac (including coronary artery bypass graft), or psychiatric disease, or signs and symptoms thereof, that may affect the subjects participation in the study, according to investigators judgement

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
Glioblastom

Medizinischer Befund
Adult patients with IDHwt, MGMT promotor methylated glioblastoma at first relapse

MedDRA Term
Glioblastoma

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Dr. med. Andreas Gustafsson Thieme

andreas.thieme@uk-essen.de

Hufelandstraße 55
45147 Essen

Sponsor

University Medicine Essen Clinician Scientist Academy (UMEA)

Einschlusskriterien
– Betroffene mit SCA3 oder SCA6 oder neurologisch gesunde Teilnehmer
– Mindestalter von 18 Jahren

Ausschlusskriterien
– Drogen- oder Alkoholabhängigkeit
– Einnahme von zentral-wirksamen Medikamenten
– Vorliegen von neurologischen oder psychiatrischen Erkrankungen ausgenommen SCA3 oder SCA6

Studienteilnehmende Mindestalter
18 Jahr(e)

Geschlecht
Divers, Männlich, Weiblich

Indikation
CEREBELLUM – Kleinhirn / Ataxie

Medizinischer Befund
Spinozerebelläre Ataxie Typ 3 (SCA3) und Spinozerebelläre Ataxie Typ 6 (SCA6)

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Köhrmann

martin.koehrmann@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Janssen-Cilag International NV (BE)

Einschlusskriterien
– Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (=) 6
– Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
– Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
– A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
– Willing and able to adhere to the lifestyle restrictions specified in this protocol

Ausschlusskriterien
– Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (>) 1 year prior with adequate treatment
– The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
– The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial [TOAST] Other Determined Etiology), based on local standard-of-care investigations
– Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
– Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
– Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

Studienteilnehmende Mindestalter
40 Jahr(e)

Geschlecht
Männlich, Weiblich

Indikation
STROKE  – Schlaganfall

Medizinischer Befund
Ischemic Stroke\nTransient Ischemic Attack

Institute
Klinik für Neurologie, Westdeutsches Tumorzentrum

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Martin Glas

neuroonkologie@uk-essen.de

Hufelandstr 55
45147 Essen

Einschlusskriterien
o Alter mindestens 18 Jahre
o Neudiagnose eines primären Glioblastoms (IDH-Wildtyp)
o Nie zuvor Radio- oder Chemotherapie erhalten
o Karnofsky Index >=70 %
o Keine Schädel-Hirntraumata in der Vergangenheit, die zu einem Aufsuchen des Arztes geführt haben
o Keine Infektionszeichen im Sinne eines respiratorischen Infekts bei Einschluss (Hinweis: Einschluss möglich, wenn erhöhter CRP/PCT Wert ohne Anzeichen eines respiratorischen Infekts)
o Keine signifikante Aphasie: ausgeprägte Verständigungsprobleme, die eine Teilnahme an und/oder das Verständnis von einer oder mehrerer geplanter Untersuchungen behindert; Bei V.a. relevante Sprachstörung ist zur Bestätigung und Analyse eine logopädische Testung geplant (modifizierter Aachener Aphasie Test, Aachener Aphasie Bedside Test und Aphasie Check Liste)

Ausschlusskriterien
o Vorhandensein folgender Erkrankungen, die zur Riechfunktion führen können:
-Neurodegenerative Erkrankungen (z.B. Parkinsonerkrankungen, Morbus Alzheimer, Chorea Huntington, Korsakowsyndrom, Morbus Pick, Shy-Drager
Syndrom)
-Tumore oder Operationen im Kopf- oder Halsbereich mit Ausnahme eines Hirntumors oder der Operation an einem Hirntumor
-Respiratorischer Infektion insbesondere der oberen Atemwege
-Zustand nach Infekten, die zur dauerhaften Beeinträchtigung der Riechfunktion geführt haben (z.B. Influenza, Corona ect.)
o Erkrankungen, die im Ermessen des Untersuchers die Durchführung der Studie beeinträchtigen (z.B. Schizophrenie)

Studienteilnehmende Mindestalter
18 Jahr(e)

Indikation
Glioblastom

Medizinischer Befund
Glioblastom

Institut
Klinik für Neurologie

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Dagny Holle-Lee

dagny.holle-lee@uk-essen.de

Hufelandstr. 55
45147 Essen

Sponsor

tame GmbH

Oelkerstraße 14a
22769 Hamburg

Indikation
WKZ – Kopfschmerzstudien

Medizinischer Befund
Migräne

Institute
Klinik für Neurologie, Klinik für Hämatologie und Stammzelltransplantation

Prüfarzt (AMG) / Studienleitung (BO)

Prof. Dr. med. Refik Pul

refik.pul@uk-essen.de

Hufelandstr 55
45147 Essen

Sponsor

Bristol-Myers Squibb GmbH & Co. KGaA

Arnulfstraße 29
80636 München

Einschlusskriterien
– Relapsing forms of Multiple Sclerosis (RMS) – Cohort 1.
i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.
ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.
– Progressive forms of MS – Cohort 2.
i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.
ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).

Ausschlusskriterien
– Participants that cannot complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
– Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
– Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.
– Other protocol-defined Inclusion/Exclusion criteria apply.

Studienteilnehmende Mindestalter
18 Jahr(e)

Studienteilnehmende Höchstalter
60 Jahr(e)

Geschlecht
Divers, Männlich, Weiblich

Indikation
MS – Multiple Sklerose, Phase I Studie

Medizinischer Befund
Multiple Sclerosis (RMS)\nProgressive Forms of Multiple Sclerosis (PMS)