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NCT02410278 · ClinicalTrials.gov registry record · Phase 4
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
A Phase 4 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT02410278 is a Phase 4 study that has completed, run by Biogen. The registered enrollment target is 102 participants.
The verdict
NCT02410278, a Phase 4 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as follows: To evaluate whether montelukast after oral administration of DMF in participants with relapsing forms of MS decreases discontinuations due to GI events and reduces the number of participants taking symptomatic therapies for GI events; To investigate the effect of montelukast on the incidence of flushing events after oral administration of 240 mg DMF in participants with relapsing forms of MS.
Interventions
- DRUG Placebo
- DRUG montelukast
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-03-12 |
| Est. Completion | 2017-04-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02410278
The ClinicalTrials.gov registry entry for NCT02410278 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 102 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 3 interventions - of which Placebo is the first listed.
NCT02410278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02410278 about?
NCT02410278 is a clinical study titled "Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera". The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with relapsing forms of Multiple Sclerosi...
What is the current status of trial NCT02410278?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2015-03-12. Estimated completion is 2017-04-27.
What interventions are being tested in trial NCT02410278?
The interventions under investigation include: Placebo (DRUG), montelukast (DRUG), dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT02410278?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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