Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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 Study.