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 SclerosisEstudio de extensión, multicéntrico y con dosis ciega para determinar la seguridad y la eficacia a largo plazo de dos dosis de BG00012 en monoterapia en pacientes con esclerosis múltiple recidivante-remitente - N/A

Phase 1

• Conditions: Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente; MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-01
• Study Completion: 2019-11-08
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use protected health information (PHI) in accordance with national and local subject privacy regulations.

2. 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 the modified visit schedule.

3. All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last does of study treatment.
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:

1. 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.

2. 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.

3. 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.

4. History of malignancy.

5. History of severe allergic or anaphylactic reactions.

6. Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyltransferase.

7. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.

8. Previous participation in this study (109MS303).

9. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol.

10. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment. (GGT) >3 times the upper limit of normal (ULN).

Study & Design

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