Phase
Condition
Memory Loss
Multiple Sclerosis
Scar Tissue
Treatment
Peginterferon Beta-1a
Dimethyl Fumarate
Placebo
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Must have a diagnosis of RRMS as defined by the revised consensus definition forpediatric 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), ormust have evidence of asymptomatic disease activity seen on MRI in the 6 months priorto 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 ofwhether the event is a first or subsequent demyelinating event.
Exclusion
Key Exclusion Criteria:
- Participants having primary progressive, secondary progressive, or progressive RMS.
- Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmunedisorders, 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/orother major disease and/or laboratory abnormality indicative thereof, that wouldpreclude participation in a clinical study
- Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/orthe subject has not stabilized from a previous relapse prior to randomization NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Research Site
Medellín,
ColombiaSite Not Available
Research Site
Tallinn, 11315
EstoniaSite Not Available
Research Site
Budapest, 1083
HungarySite Not Available
Research Site
Ar-Ramtha,
JordanSite Not Available
Research Site
Seoul, 06351
Korea, Republic ofSite Not Available
Research Site
Penang,
MalaysiaSite Not Available
Research Site
Petaling Jaya,
MalaysiaSite Not Available
Research Site
Petaling Jaya, Selangor,
MalaysiaSite Not Available
Research Site
Seberang Jaya,
MalaysiaSite Not Available
Research Site
Federal District,
MexicoSite Not Available
Research Site
Guadalajara,
MexicoSite Not Available
Research Site
Morelia,
MexicoSite Not Available
Research Site
Santa Cruz,
MexicoSite Not Available
Research Site
Dammam,
Saudi ArabiaSite Not Available
Research Site
Riyadh,
Saudi ArabiaSite Not Available
Research Site
Taipei, 10002
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Bangkok,
ThailandSite Not Available
Research Site
Pathumwan,
ThailandSite Not Available
Research Site
Mannouba,
TunisiaSite Not Available
Research Site
Manouba,
TunisiaSite Not Available
Research Site
Monastir,
TunisiaSite Not Available
Research Site
Sfax,
TunisiaSite Not Available
Research Site
Tunis,
TunisiaSite Not Available
Research Site
Ankara,
TurkeySite Not Available
Research Site
Izmir,
TurkeySite Not Available
Research Site
Samsun,
TurkeySite Not Available
Research Site
Raleigh, North Carolina 27607
United StatesSite Not Available
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