Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration
What it found
The trial was stopped early because the treatment was not working.
Reason given: Study did not meet required enrollment numbers
What was tested
Treatment tested
- Simethicone
Antifoaming agent
- Loperamide
- Peanut Butter
Results by group
Reported GI Symptoms
7 Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Control Group | 0 | 0 | |
| Treatment Arm | 0 | 0 |
Control Group
Treatment Arm
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Control Group | 1 | 0 (0.0%) | |
| Treatment Arm | 4 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Reported GI Symptoms
7 Weeks
Other measures (1)
Diarrhea Reduction
7 Weeks
Who could take part
Relapsing MS · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jul 2014
Main results due
Jun 2015
Finished
Jun 2015
Results posted
Jan 2017