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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BG00012

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

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

dimethyl fumarate administered as per the arm description

Interventions

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dimethyl fumarate

dimethyl fumarate administered as per the arm description

Intervention Type DRUG

Other Intervention Names

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Tecfidera DMF BG00012

Eligibility Criteria

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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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No