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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 is a Phase 4 study that has completed, run by Biogen. The registered enrollment target is 237 participants.
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.
Interventions
- DRUG BG00012 (DMF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01873417
The ClinicalTrials.gov registry entry for NCT01873417 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 237 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 BG00012 (DMF) is the first listed.
NCT01873417 reports 0 study locations.
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.
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