Status:
TERMINATED
Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Lead Sponsor:
Rocky Mountain MS Research Group, LLC
Collaborating Sponsors:
Biogen
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Decision to treat with DMF must precede enrollment
- 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
- Men or women 18 years of age or older at the time of informed consent
- Naïve to DMF or fumaric acid esters
- Confirmed diagnosis of a relapsing form of multiple sclerosis as verified by the Principal Investigator
Exclusion
- Unable to unwilling to comply with study requirements as outlined in the informed consent
- Known active malignancies or any other major comorbidities that, in the opinion of the Investigator, would affect the outcome of the study
- 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
- Previous treatment with dimethyl fumarate
- 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
- Known sensitivity or allergic reaction to peanuts, simethicone, or loperamide
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02217982
Start Date
July 1 2014
End Date
June 1 2015
Last Update
March 23 2017
Active Locations (1)
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1
Rocky Mountain MS Research Group
Salt Lake City, Utah, United States, 84103