Relapsing Remitting Multiple SclerosisPhase 4IIT9NCT02217982
Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
A Phase 4 study testing Simethicone, Loperamide and Peanut Butter in people with Relapsing Remitting Multiple Sclerosis, run by Rocky Mountain MS Research Group, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Simethicone, Loperamide and Peanut Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain MS Research Group
Salt Lake City, Utah, 84103
About this study
Official title: 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.
Read more
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
- Being tested
- Simethicone, Loperamide, Peanut Butter
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
Also called Gas-X
LoperamideDrug
Also called Imodium
Peanut ButterOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Simethicone; Drug: Loperamide; Other: Peanut Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 Weeks
Secondary outcomes (1)
Diarrhea Reduction
The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.
Measured: 7 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Study did not meet required enrollment numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain MS Research Group, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Principal investigator, John F. Foley, MD, Rocky Mountain MS Research Group, LLC
- Investigators
- John F Foley, MD, Principal investigator, Rocky Mountain MS Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217982
- Sponsor's protocol ID
- 009-001-TEC
- Acronym
- IIT9
- Status last verified
- Feb 2017
- First submitted
- 30 Jul 2014
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Dimethyl Fumarate (Tecfidera) Related GI Symptom Mitigation Via Food Bolus Alteration and Simethicone/Loperamide Administration
- ClinicalTrials.gov ID
- NCT02217982
- Acronym / sponsor ID
- IIT9 / 009-001-TEC
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study did not meet required enrollment numbers
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rocky Mountain MS Research Group, LLCUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Simethicone, Drug: Loperamide, Other: Peanut ButterPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimethiconeAlso: Gas-X | Drug | Treatment Arm |
| LoperamideAlso: Imodium | Drug | Treatment Arm |
| Peanut Butter | Other | Treatment Arm |
Primary outcome
Reported GI Symptoms
Time frame: 7 Weeks
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.
1 secondary outcome
Diarrhea Reduction
Time frame: 7 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Foley, MD principal investigator
Rocky Mountain MS Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simethicone, Loperamide and Peanut Butter in people with Relapsing Remitting Multiple Sclerosis, run by Rocky Mountain MS Research Group, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported GI Symptoms (time frame: 7 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.