Tecfidera Slow-titration Study
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/11/2016 |
| Start Date: | April 2015 |
| End Date: | December 2015 |
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.
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.
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-β, 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
We found this trial at
19
sites
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