Overview

This trial is active, not recruiting.

Condition multiple sclerosis, relapsing-remitting
Treatment dimethyl fumarate
Phase phase 3
Sponsor Biogen
Start date April 2014
End date October 2016
Trial size 221 participants
Trial identifier NCT02579681, 109MS410, 2013-001422-25, ITA-BGT-12-10389

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter.
dimethyl fumarate Tecfidera
dimethyl fumarate administered as per the arm description

Primary Outcomes

Measure
Proportion of patients with worsening in cognitive improvement over 2 years.
time frame: Up to 2 years

Secondary Outcomes

Measure
Change in cognitive impairment index score (CII) over two years
time frame: Up to 2 years
Annualized relapse rate at year 1.
time frame: Up to one year
Annualized relapse rate at year 2.
time frame: Up to 2 years
Time to relapse over 2 years.
time frame: 2 years
Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).
time frame: Up to 2 years
Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
time frame: Up to 2 years
Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)
time frame: 2 years
Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)
time frame: 2 years
Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey
time frame: 2 years
Change from baseline in the Environmental Status Scale (ESS)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Biogen.