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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 is a Phase 4 study that was terminated before completion, run by Rocky Mountain MS Research Group. The registered enrollment target is 5 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02217982
The ClinicalTrials.gov registry entry for NCT02217982 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rocky Mountain MS Research Group, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Loperamide is the first listed.
NCT02217982 reports 0 study locations.
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.
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