Safety and Efficacy of BG00012 in Relapsing Remitting Multiple Sclerosis

A Randomized, Multicentre, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Safety and Efficacy of BG00012 in Subjects with Relapsing Remitting Multiple Sclerosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000124437

Enrollment

1011

Registered

2007-02-12

Start date

2006-12-15

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The purpose of the study is to determine whether BG00012 is effective in reducing the proportion of patients experiencing a clinical relapse at 2 years compared to placebo in patients with relapsing remitting multiple sclerosis. Two different doses of BG00012 will be compared to placebo. Patients will be randomised to one of 3 groups in a 1:1:1 ratio: Group 1 will receive 480 mg daily orally via 2 capsules 3 times daily. Each capsule will contain either 120 mg BG00012 or placebo. Group 2 will receive 720 mg daily orally via 2 capsules 3 times daily. Each capsule will contain 120 mg BG00012. Group 3 will receive placebo orally via 2 capsules 3 times daily. Patients will have the option of switching to open label Avonex (interferon beta-1a) if they experience relapse after 24 weeks and have completed 48 weeks of double blind treatment, OR they experience disability progression sustained for 12 weeks at any time.

Interventions

BG00012; Group 1 will receive 480 mg daily orally via 2 capsules 3 times daily. Each capsule will contain either 120 mg BG00012 or placebo (lactose monohydrate). Group 2 will receive 720 mg daily orally via 2 capsules 3 times daily. Each capsule will contain 120 mg BG00012. Treatment will be for 2 years.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Confirmed diagnosis of relapsing remitting multiple sclerosis according to McDonald criteria #1-4At least 1 relapse within 12 months prior to randomization with cranial MRI demonstrating MS consistent lesions, OR evidence of Gadolinium enhancing brain lesions on MRI within 6 weeks prior to randomisationBaseline Expanded Disability Status Score (EDSS) between 0.0 and 5.0.

Exclusion criteria

Primary progressive, secondary progressive or progressive relapsing Multiple SclerosisAn MS relapse within 50 days of randomisation OR a patient who has not stabilised from a previous relapse prior to randomisationInability to perform Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, PASAT 3, or Visual Function testHistory of MalignancyHistory of severe allergic or anaphylactic reactions/known drug hypersensitivityHistory of HIVHistory of Drug or Alcohol abuse in last 2 yearsPositive for Hep C antibody and/or Hep B surface antigenAbnormal laboratory results indicative of major disease which would preclude clinical trial participationAny previous treatment with FUMADERM or BG00012/FAG-201History of other disallowed medication use outside of the time-frames specified in the protocolWomen of child-bearing potential not using adequate contraceptionEnrolment in other clinical trials within 6 months prior to randomisation.

Outcome results