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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02428231
Other study ID # 109MS416
Secondary ID 2014-004562-22
Status Terminated
Phase Phase 3
First received April 23, 2015
Last updated August 9, 2016
Start date April 2015
Est. completion date December 2015

Study information

Verified date August 2016
Source Biogen
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlUnited States: Food and Drug AdministrationItaly: The Italian Medicines Agency
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF)-related gastrointestinal (GI) Adverse Events (AEs) in subjects with Multiple Sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of dimethyl fumarate treatment in this study population.


Recruitment information / eligibility

Status Terminated
Enrollment 62
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria:

- Diagnosis of MS consistent with locally labeled indication for dimethyl fumarate

- No prior treatment with dimethyl fumarate

- Female subjects of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study

- Have had a recent complete blood count (CBC), including lymphocyte count, that does not preclude participation in the study

Key Exclusion Criteria:

- Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with GI signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints

- Have other comorbid conditions that preclude participation in the study

- Participant is pregnant, breastfeeding, or planning a pregnancy during the study period

- Are receiving concomitant disease-modifying therapies for MS including, but not limited to, natalizumab, IFN-ß, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening

- History of severe allergic or anaphylactic reactions or known drug hypersensitivity

- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
dimethyl fumarate
Participants will be dosed twice daily for 12 weeks.

Locations

Country Name City State
Belgium Research Site Leuven
Belgium Research Site Wilrijk
Czech Republic Research Site Praha 5
Italy Research Site Merano Bolzano
Italy Research Site Montichiari Brescia
United States Research Site Asheville North Carolina
United States Research Site Auburn Maine
United States Research Site Avon Indiana
United States Research Site Charlotte North Carolina
United States Research Site Dallas Texas
United States Research Site Dayton Ohio
United States Research Site Franklin Indiana
United States Research Site Gilbert Arizona
United States Research Site Indianapolis Indiana
United States Research Site Long Beach California
United States Research Site Miami Florida
United States Research Site Overland Park Kansas
United States Research Site Phoenix Arizona
United States Research Site Raleigh North Carolina
United States Research Site Wenatchee Washington
United States Research Site West Palm Beach Florida
United States Research Site Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with worsening severity of gastrointestinal (GI) Adverse Events (AEs) Positive average change from baseline to end of dimethyl fumarate treatment in the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It has been modified for daily recall in this study. The 7 severities of each of the 15 questions of the GSRS have a number assigned from 0 (no discomfort at all) to 6 (very severe discomfort). 6 weeks No
Secondary Average change from baseline in GSRS scores during dimethyl fumarate treatment 12 weeks No
Secondary Time to first worsening from baseline in GSRS score 14 weeks No
Secondary Time to recovery to baseline from last occurrence of worst GSRS score 14 weeks No
Secondary Average change from baseline in GSRS scores to the end of Weeks 4, 6, 8, 10, 12, and 14 14 weeks No
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