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



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:10 - 17
Updated:12/6/2018
Start Date:February 22, 2016
End Date:September 24, 2018

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

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).


Key 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.

Key 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.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
We found this trial at
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Loma Linda, CA
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Ghent,
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