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Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate

NCT02090348 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-09-07

No results posted yet for this study

Summary

The primary objective of this study is to determine whether dimethyl fumarate (DMF) taken over 12 months is effective in reducing Multiple Sclerosis (MS)-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are: To investigate changes from Baseline in FSMC and fatigue severity (Fatigue Severity Scale \[FSS\]) at 1, 3, 6, 9, and 12 months in participants receiving DMF; To assess the impact of DMF on patient-reported outcomes (PROs), including work productivity (Work Productivity and Activity Impairment-Multiple Sclerosis questionnaire \[WPAI-MS\]), health-related quality of life (Short Form Health Survey \[SF-12\]), depression (Beck Depression Inventory-Fast Screen \[BDI-FS\]), and sleepiness (Epworth Sleepiness Scale \[ESS\]) at 6 and 12 months in participants receiving DMF; To examine whether an association exists between fatigue and baseline demographics (e.g., age and sex) and disease characteristics (e.g., disease duration, baseline disease activity, treatment history, expanded disability status scale \[EDSS\] score, and PROs); To assess any changes in fatigue-related medication use.

Conditions

Interventions

DRUG

dimethyl fumarate

Administered as specified in the treatment arm

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-10-31
Completion
2017-10-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02090348 on ClinicalTrials.gov