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Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | Clinical Trials | Clareo Health

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Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis

NCT02555215•Biogen

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
•Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.

Exclusion Criteria

•Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
•Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
•Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

Locations (12)

Research Site

Loma Linda, California, United States

Research Site

Ghent, Belgium

Research Site

Sofia, Bulgaria

Research Site

Hradec Králové, Czechia

Research Site

Munich, Bavaria, Germany

Research Site

Göttingen, Lower Saxony, Germany

Research Site

Kuwait City, Kuwait

Research Site

Riga, Latvia

Research Site

Beirut, Lebanon

Research Site

Gdansk, Poland

Key Dates

Start Date

February 22, 2016

Primary Completion Date

September 24, 2018

Completion Date

September 24, 2018

Last Updated

November 22, 2019

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

dimethyl fumarate

DRUG

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

NCT05359653

Multiple Sclerosis (MS)Multiple Sclerosis, Relapsing-Remitting+5 more

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RECRUITINGNA

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

NCT06390930

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Inclusion Criteria

Exclusion Criteria

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis

Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS

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