A clinical trial to determine the efficacy and safety of BG00012 in patients with relapsing remitting multiple sclerosis.

A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000117

Enrollment

1232

Registered

2009-10-30

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

None listed

Interventions

Intervention1: BG00012: 240mg capsules TID Intervention2: BG00012: 240mg capsules BID Control Intervention1: Placebo: to match Control Intervention2: Copaxone (Glatiramer Acetate): 20mg SC Inj. once d

Eligibility

Inclusion criteria

Inclusion criteria: a). Aged 18 to 55 years old, inclusive at the time of informed consent. b). Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4. c). Must have a baseline EDSS between 0.0 and 5.0, inclusive. d). Must have relapsing-remitting disease course.

Exclusion criteria

Exclusion criteria: a). Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease b). Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
To determine whether BG00012, when compared with placebo is effective in reducing the rate of clinical relapses at 2 years.Timepoint: 2 years	—

Secondary

Measure	Time frame
If BG00012 decreases number of brain lesions, slows time to progression, the safety and tolerability, and effect it has on MS tests and evaluations. Commercially available glatiramer acetate is being used to compare its benefits and risks with placebo.Timepoint: 2 years	—

Countries

India

Contacts

Public ContactMandeep Kaushal

Medical Director

amish.vora@biogenidec.com0124 4572304

Outcome results