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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: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT02428231 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying
Interventions
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Why NCT02428231 stopped before completion
NCT02428231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which dimethyl fumarate is the first listed.
NCT02428231 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02428231's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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