A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A

Phase 1

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2008-004753-14-GR
• Lead Sponsor: Biogen Idec Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-21
• Study Completion: 2019-11-08
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1738

Inclusion Criteria

1.Must give written informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]).
2. Aged 18 to 55 years old, inclusive, at the time of informed consent and enrolment into the 109MS301 or 109MS302 trial.
3. Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 and 109MS302, including those subjects who received an open-label, approved MS therapy and completed a modified visit schedule, are eligible to participate in this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Reasons for study exclusion include:

Any significant change in medical history in subjects from 109MS301 or 109MS302, including laboratory tests, or current clinically significant condition that in the opinion of the Investigator would have excluded the subjects' participation from their previous study. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.

Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.

Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified weekly schedule up to Week 96.

Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl-transferase (GGT) >3 times the upper limit of normal (ULN).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified