Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation

NCT02217982 | Terminated Phase 4 Results

• 1 other identifier: 009-001-TEC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Reported GI Symptoms

  The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.

  7 Weeks

Secondary Outcomes (1)

• Diarrhea Reduction

  7 Weeks

Other Outcomes (1)

• Number of Participants With Pre-Existing GI Conditions

  7 Weeks

Study Arms (2)

Control Group

NO INTERVENTION

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.

Treatment Arm

ACTIVE COMPARATOR

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.

Drug: Simethicone; Drug: Loperamide; Other: Peanut Butter

Interventions

Simethicone DRUG

Also known as: Gas-X

Treatment Arm

Loperamide DRUG

Also known as: Imodium

Treatment Arm

Peanut Butter OTHER

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known sensitivity or allergic reaction to peanuts, simethicone, or loperamide

Sponsors & Collaborators

• Rocky Mountain MS Research Group, LLC: lead
• Biogen: collaborator

Study Sites (1)

Rocky Mountain MS Research Group

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Simethicone; Loperamide

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This trial was closed down early because the anticipated number of patients experiencing GI symptoms was not met - therefore not enough patients qualified for the treatment and control arms for analysis.

Results Point of Contact

• Title: Tammy Hoyt
• Organization: Rocky Mountain MS Research Group

thoyt@rmmsc.com

8014085711

Study Officials

• John F Foley, MD

  Rocky Mountain MS Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 23, 2017
• Results First Posted: January 6, 2017

Record last verified: 2017-02

Locations

US (1)