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NCT02428231 · ClinicalTrials.gov registry record · Phase 3
Tecfidera Slow-Titration Study
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT02428231 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 62 participants.
The verdict
NCT02428231, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study 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 \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants 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 DMF treatment in this study population.
Interventions
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02428231
The ClinicalTrials.gov registry entry for NCT02428231 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dimethyl fumarate is the first listed.
NCT02428231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02428231 about?
NCT02428231 is a clinical study titled "Tecfidera Slow-Titration Study". 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 \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary...
What is the current status of trial NCT02428231?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2015-04. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02428231?
The interventions under investigation include: dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT02428231?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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