Multiple Sclerosis Clinical Trial

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

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 other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.

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Full 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 disability progression or high lesion burden on MRI will have the option to discontinue the blinded study treatment and switch to an alternative therapy or open-label BG00012.

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Eligibility Criteria

Key Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

11

Study ID:

NCT03870763

Recruitment Status:

Terminated

Sponsor:

Biogen

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There are 6 Locations for this study

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Research Site
Raleigh North Carolina, 27607, United States
Research Site
Medellín , , Colombia
Research Site
Tallinn , 11315, Estonia
Research Site
Budapest , 1083, Hungary
Research Site
Ar-Ramtha , , Jordan
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Petaling Jaya , , Malaysia
Research Site
Seberang Jaya , , Malaysia
Research Site
Guadalajara , , Mexico
Research Site
Morelia , , Mexico
Research Site
Santa Cruz , , Mexico
Research Site
Dammam , , Saudi Arabia
Research Site
Riyadh , , Saudi Arabia
Research Site
Taipei , 10002, Taiwan
Research Site
Taoyuan , 333, Taiwan
Research Site
Bangkok , , Thailand
Research Site
Manouba , , Tunisia
Research Site
Monastir , , Tunisia
Research Site
Sfax , , Tunisia
Research Site
Tunis , , Tunisia
Research Site
Ankara , , Turkey
Research Site
Izmir , , Turkey
Research Site
Samsun , , Turkey

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

11

Study ID:

NCT03870763

Recruitment Status:

Terminated

Sponsor:


Biogen

How clear is this clinincal trial information?

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