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NCT01873417 · ClinicalTrials.gov registry record · Phase 4
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
A Phase 4 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 4
- Development phase
- 237
- Enrollment target
NCT01873417: Completed Phase 4 study, sponsored by Biogen.
NCT01873417 is a Phase 4 study that has completed, run by Biogen. The registered enrollment target is 237 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01873417, a Phase 4 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 237 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting. The secondary objectives of this study are as follows: * To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting. * To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
Primary Outcome
Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Interventions
- DRUG BG00012 (DMF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT01873417 record still lists
NCT01873417 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which BG00012 (DMF) is the first listed.
NCT01873417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01873417 about?
NCT01873417 is a clinical study titled "Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States". The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting. The secondary obj...
What is the current status of trial NCT01873417?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 237 participants. The study started on 2013-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01873417?
The interventions under investigation include: BG00012 (DMF) (DRUG).
Who is sponsoring clinical trial NCT01873417?
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 NCT01873417's enrollment target sits among peer trials
237 367th of 2000 higher than 1,634 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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