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

NCT02090348 | Withdrawn Phase 4

• 3 other identifiers: 109MS4052013-001025-53DEN-BGT-13-10413
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMF

  FSMC is a 20-item questionnaire and produces a score between 1 and 5 for each scored question (ranging from "does not apply at all" to "applies completely"). Items are summed to generate a total score and transformed to a scale with a range of 20 to 100, where higher scores indicate higher levels of fatigue

  12 months

Secondary Outcomes (9)

• Mean change from baseline in fatigue as assessed by FSMC in participants receiving DMF

  Baseline and 1, 3, 6, 9 and 12 months

• Mean change from baseline in fatigue as assessed by FSS in participants receiving DMF

  Baseline and 1, 3, 6, 9 and 12 months

• Mean change from baseline in work productivity as assessed by WPAI-MS, in participants receiving DMF

  Baseline and 6, 12 months

• Mean change from baseline in quality of life as assessed by SF-12 in participants receiving DMF

  Baseline and 6, 12 months

• Mean change from baseline in depression as assessed by BDI-FS in participants receiving DMF

  Baseline and 6, 12 months

Study Arms (1)

dimethyl fumarate

EXPERIMENTAL

DMF at a dose of 120 mg twice a day (BID) for the first 7 days and 240 mg BID for the remainder of study period (up to 12 months)

Drug: dimethyl fumarate

Interventions

dimethyl fumarate DRUG

Administered as specified in the treatment arm

Also known as: DMF, BG00012, Tecfidera

dimethyl fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a confirmed diagnosis of RRMS and satisfies the therapeutic indication as described in the local label.
• Have a stable EDSS (as assessed by the Investigator) and been on the same (type and dosage) standard of care (SOC) first-line treatment for at least 6 months.
• If taking antidepressants, amphetamine, modafinil, or fampridine (Fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the Baseline Visit.
• FSMC total score ≥43 (mild fatigue) at Baseline.
• As perceived by the Investigator, have the ability to comply with all requirements of the study protocol.

You may not qualify if:

• Diagnosis of major depression, as identified by the Investigator.
• Diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
• History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
• Treatment of MS relapse within 90 days prior to study enrollment.
• History of a positive test result for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody.
• Impaired hepatic or renal function, as perceived by the Investigator.
• Any prior treatment with DMF (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, T cell or T-cell receptor vaccination, or any therapeutic monoclonal antibody.
• Current enrollment in any other clinical studies.
• Known to suffer from narcolepsy or another significant sleep disorder.
• Comorbidity that may have an impact on fatigue.
• Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: June 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 7, 2015

Record last verified: 2015-09