A dose blind extension clinical trial to determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in patients with relapsing remitting multiple sclerosis.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000288

Enrollment

1700

Registered

2010-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Relapsing Remitting Multiple Sclerosis

Interventions

Intervention1: BG00012: 240mg capsule BID Intervention2: BG00012: 240mg Capsule TID Control Intervention1: None: None

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent. 2. Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 or 109MS302. 3. All male subjects 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 dose of study treatment.

Exclusion criteria

Exclusion criteria: 1. Any significant change in medical history or current clinically significant condition that in the opinion of the Investigator would have excluded the subject's participation. 2. Subjects who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression. 3. Subjects who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule. 4. History of malignancy, severe allergic or anaphylactic reactions. 5. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding. 6. Unwillingness or inability to comply with the requirements of the protocol. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Design outcomes

Primary

Measure	Time frame
To Evaluate The Long-Term Safety Profile Of BG00012.Timepoint: 2 Years	—

Secondary

Measure	Time frame
Health EconomicsTimepoint: 2 years;To Evaluate MS Lessions On MRI Scans.Timepoint: 2 Years;To Evaluate The LT Efficacy Of Bg12 Using Clincal Endpoints.Timepoint: 2 Years	—

Countries

India

Contacts

Public ContactMandeep Kaushal

Biogen

ritika.bajaj@biogen.com9717004620

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026