Status:
TERMINATED
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The ...
Detailed Description
Participants will be randomized in a 1:2:2 ratio to receive the double-blind study treatment (Dimethyl Fumarate, Peginterferon Beta-1a, and placebo). Participants experiencing a confirmed relapse or d...
Eligibility Criteria
Inclusion
- Key
- Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
- Must have an EDSS score between 0.0 and 5.0.
- Must have a body weight of ≥30 kg
- Must have experienced ≥1 relapse in the 12 months prior to randomization (Day 1), or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or ≥2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event.
- Key
Exclusion
- Participants having primary progressive, secondary progressive, or progressive RMS.
- Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.
- History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study
- Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03870763
Start Date
March 19 2019
End Date
July 21 2022
Last Update
June 15 2023
Active Locations (23)
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1
Research Site
Raleigh, North Carolina, United States, 27607
2
Research Site
Medellín, Colombia
3
Research Site
Tallinn, Estonia, 11315
4
Research Site
Budapest, Hungary, 1083