Treatment with dimethyl fumarate in patients with primary progressive multiple sclerosis

Phase 1

• Conditions: Primary progressive multiple sclerosis (PPMS); MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000283-41-DK
• Lead Sponsor: Finn Sellebjerg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-29
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

•Age 18 to 60 years
•PPMS according to the McDonald (2010) and Lublin (2014) criteria
•Disease duration at least one year
•Expanded Disability Status Scale (EDSS) under or equal to 6.5
•Written informed consent to study participation
•No other signs of significant disease judged by the investigator
•Eligible for randomization to active treatment or placebo as assessed by cerebrospinal fluid (CSF) Neurofilament light chain (NFL) levels above
380ng/L
•Not eligible for randomization as assessed by CSF biomarker studies but accepts follow-up and open-label treatment per protocol
•Patients not eligible for randomization due to low NFL concentrations in CSF at screening can be followed up after 48 weeks, and are eligible for open-label treatment if they fulfil one of the following clinical criteria of disease progression:
•1 point increase in EDSS score from screening to week 48 if screening EDSS less than 6
•0.5 point increase in EDSS score from screening to week 48 if screening EDSS is more than 5.5
•2 point increase in a physical functional system
•Worsening in Symbol Digit Modalities Test, 9 hole peg test or timed 25 foot walk test more than 20% from screening to week 48

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnancy or breast feeding
•Lack of effective contraception for women of child-bearing potential
•Relapse within 6 months of inclusion
•Methylprednisolone treatment within 3 months of inclusion
•Treatment with interferon-beta, glatiramer acetate, immunoglobulin G or other immunomodulatory treatment within 6 months of inclusion
•Treatment with mitoxantrone, cyclophosphamide, azathioprine or other immunosuppressive treatment within 6 months of inclusion
•Findings on the screening MRI judged to preclude participation by the treating physician
•Other diseases associated with immunodeficiency
•Other diseases judged to be relevant by the treating physician
•Anticoagulant therapy other than platelet inhibitors
•Active malignant disease in the previous 5 years
•Renal insuffiency or blood creatinine more than 150 µmol/l
•Present or chronic infection with hepatitis B virus, hepatitis C virus, HIV (tested in the screening blood samples) or other infections found to be relevant by the treating physician.
•Psychiatric disorders or other disorders impairing the patient’s ability to participate in the trial
•Contraindication to MRI
•Known allergy or hypersensitivity to dimethyl fumarate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified