Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02217982
• Date of registration: 30/07/2014
• Prospective Registration: No
• Primary sponsor: Rocky Mountain MS Research Group, LLC
• Public title: Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation IIT9
• Scientific title: A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration
• Date of first enrolment: July 2014
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02217982
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: John F Foley, MD
• Affiliation: Rocky Mountain MS Research Group

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: Loperamide

Other: Peanut Butter

Drug: Simethicone

Primary Outcome(s)

Reported GI Symptoms [Time Frame: 7 Weeks]

Secondary Outcome(s)

Diarrhea Reduction [Time Frame: 7 Weeks]

Secondary ID(s)

009-001-TEC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen

Results

• Results available: Yes
• Date Posted: 06/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02217982