Multiple Sclerosis Clinical Trial
— TITRATIONOfficial title:
A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Biogen |
United States, Belgium, Czech Republic, Italy,
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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