Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | June 2015 |
A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration
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.
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.
Inclusion Criteria:
1. Decision to treat with DMF must precede enrollment
2. Ability to understand the purpose and risk of the study and provide authorization for
the use of protected health information in accordance with the monitoring agency
3. Men or women 18 years of age or older at the time of informed consent
4. Naïve to DMF or fumaric acid esters
5. Confirmed diagnosis of a relapsing form of multiple sclerosis as verified by the
Principal Investigator
Exclusion Criteria:
1. Unable to unwilling to comply with study requirements as outlined in the informed
consent
2. Known active malignancies or any other major comorbidities that, in the opinion of
the Investigator, would affect the outcome of the study
3. Pregnant or breastfeeding or likely to become pregnant during the course of the
study. Women of child-bearing potential must practice an acceptable form of birth
control
4. Previous treatment with dimethyl fumarate
5. Past history of GI malignancy, gastric ulceration refractory to medical resolution,
history of gastrectomy. At the discretion of the PI, resolved GI ulceration,
gastroesophageal reflux will not be exclusionary
6. Known sensitivity or allergic reaction to peanuts, simethicone, or loperamide
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