Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 (StarTec)

Biogen

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02579681

2013-001422-25 (EudraCT Number)

109MS410 (Other Identifier)

ITA-BGT-12-10389

Details and patient eligibility

About

The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
• Must have a baseline EDSS between 0.0 and 5.0, inclusive.
• Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.

Key Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:

• Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
• Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
• History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
• An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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221 participants in 1 patient group

BG00012

Experimental group

Description:

BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter.

Treatment:

Drug: dimethyl fumarate