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NCT02217982 · ClinicalTrials.gov registry record · Phase 4
Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
A Phase 4 study, sponsored by Rocky Mountain MS Research Group.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT02217982: Clinical Trial Phase 4 study, sponsored by Rocky Mountain MS Research Group.
NCT02217982 is a Phase 4 study that was terminated before completion, run by Rocky Mountain MS Research Group. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02217982, a Phase 4 study, was terminated before completion, sponsored by Rocky Mountain MS Research Group.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Single site, open label, randomized design in patients with relapsing forms of Multiple Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF), including the titration period. After two weeks or if a patient experiences 3 or more consecutive days of GI symptoms in any category of ≥3.5, the patient will return for a Baseline Visit. The MAGIS diary will be reviewed by the coordinator. Any patient who has reported an average MAGIS score of greater than or equal to 3.5 in at least one of the key categories will be randomized to a standard therapy or treatment arm. Patients who report a MAGIS of less than 3.5 during this period will be terminated from the study at this visit. Patients with an average reported MAGIS of greater than 6.5 at Baseline will be placed in the treatment arm. Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter) 10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily. Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS \>6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily. Both treatment arms will be observed for 6 weeks. MAGIS will be recorded once daily. Patients will return to the clinic at Week 3 and Week 6/End of Treatment for diary and compliance review. After Week 6, patients will be instructed to return to a standard therapy. MAGIS will be recorded for one more week and collected at Week 7/End of
Primary Outcome
The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.
Interventions
- DRUG Loperamide
- DRUG Simethicone
- OTHER Peanut Butter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
Why NCT02217982 stopped before completion
NCT02217982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Loperamide is the first listed.
NCT02217982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02217982 about?
NCT02217982 is a clinical study titled "Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation". Single site, open label, randomized design in patients with relapsing forms of Multiple Sclerosis. At the Screening Visit, the patient will be given a diary containing the MAGIS scale to be completed once a day for the first two weeks while on Dimethyl Fumarate (DMF), including the titration period....
What is the current status of trial NCT02217982?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2014-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02217982?
The interventions under investigation include: Loperamide (DRUG), Simethicone (DRUG), Peanut Butter (OTHER).
Who is sponsoring clinical trial NCT02217982?
This trial is sponsored by Rocky Mountain MS Research Group, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02217982's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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