Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis (DEFINE)

Biogen

Status and phase: Completed; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: BG00012; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420212

109MS301

Details and patient eligibility

About

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Enrollment: 1,234 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
• Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
• Must have a baseline EDSS between 0.0 and 5.0, inclusive.
• Must have relapsing-remitting disease course.

Key Exclusion Criteria:

• Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
• Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
• Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,234 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received two placebo capsules orally three times daily (TID)

Treatment:

Drug: Placebo

BG00012 240 mg Twice Daily (BID)

Experimental group

Description:

Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)

Treatment:

Drug: BG00012

BG00012 240 mg 3 Times Daily (TID)

Experimental group

Description:

Participants received two 120 mg BG00012 capsules orally three times daily (TID)

Treatment:

Drug: BG00012