Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Intervention1: BG00012: Route: Oral
Experimental: Dimethyl Fumarate 240 mg
Participants will receive dimethyl fumarate 240 milligrams (mg) capsule twice daily (BID) orally and placebo subcutaneous (S
Sponsors
Biogen MA Inc Biogen Idec Research Limited
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS 2 Must have an EDSS score between 0.0 and 5.0. 3 Must have a body weight of �30 kg 4 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
Exclusion criteria
Exclusion criteria: 1 Participants having primary progressive, secondary progressive, or progressive RMS. 2 Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders. 3 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 4 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvementTimepoint: A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Timepoint: Time Frame: Baseline up to Week 100;2. Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) ScansTimepoint: Time Frame: Weeks 48 and 96;3.Number of Galdolinium(Gd)-Enhancing LesionsTimepoint: Time Frame: Weeks 48 and 96;4.Annualized Relapse RateTimepoint: Time Frame: Weeks 48 and 96 | — |
Countries
Colombia, Estonia, Hungary, India, Jordan, Malaysia, Mexico, Republic of Korea, Romania, Saudi Arabia, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United States of America
Contacts
Public ContactSuneela Thatte
IQVIA RDS (India) Private Limited
Outcome results
None listed