Relapsing Remitting Multiple SclerosisPERSISTNCT04925778
Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate
An observational study of Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC.
Trial summary
This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam®. 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?
- monomethyl fumarate
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 29 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis currently treated with dimethyl fumarate (DMF), and experiencing gastrointestinal symptoms attributable to DMF are eligible. Sufficient patients will be enrolled until 50 evaluable patients complete the study.
Who may be able to join
- Male or non-pregnant female aged 18years and older.
- Diagnosis of RRMS (per McDonald 2010 Criteria) at screening [Polman 2011].
- Currently being treated with dimethyl fumarate (DMF; Tecfidera® or generic equivalent). At least 1 week and 1 day of continuous treatment with DMF monotherapy prior to initiation of Bafiertam®. Note: continuous treatment with DMF is defined as treatment uninterrupted by other disease-modifying treatment.
- GI symptoms (defined as any combination of abdominal pain, nausea, vomiting, diarrhea, constipation, bloating, or flatulence) while receiving treatment with DMF.
- Must be naïve to Bafiertam®.
- Additional inclusion criteria apply
Who cannot join
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014].
- Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
- History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient (monomethyl fumarate), dimethyl fumarate, diroximel fumarate (Vumerity®), or any of the excipients.
- Lymphocyte counts less than 1000/microliter. Any other clinically significant abnormalities in CBC, blood and urine chemistries, or liver function tests in the past 30 days.
- History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML) and herpes zoster) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- Any prior suspicion of PML.
- 9. Additional exclusion criteria apply.
About this study
Official title: An Open-label, Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® (Monomethyl Fumarate) From Dimethyl Fumarate (PERSIST)
This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam®.
Read the detailed description
This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam® (monomethyl fumarate).
Adult patients with a diagnosis of RRMS receiving continuous treatment with DMF monotherapy and who are experiencing GI symptoms will be eligible to enroll in the study.
Patients will be identified and screened by chart review and invited to report GI Symptoms for one baseline week using a study app downloaded on their own smartphone/tablet. During this week, patients will continue their currently prescribed and remaining DMF treatment and will record their GI symptoms daily using the app.
At the end of the Baseline Period, patients will be asked to cease administration of the DMF, and to commence self-treatment with Bafiertam® 95 mg capsules twice a day (total daily dose of 380 mg) approximately 12 hours apart the following day for 28 days. They will be required to continue to record their GI symptoms each day.
On Day 28; End-of Study [EOS]) the patient's diary will be reviewed, adverse events (AE) recorded, and drug accountability performed.
Following EOS patients will be asked if they wish to continue Bafiertam® treatment. Those patients who elect to continue will be contacted one month and two months after EOS to ascertain if they remain on Bafiertam®.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- monomethyl fumarate
- Keywords
- Bafiertam, Tecfidera, dimethyl fumarate, monomethyl fumarate, gastrointestinal
- 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.
monomethyl fumarateDrug
Also called Bafiertam®, BLS-11
Patients will be prescribed 190 mg (two 95 mg capsules) self-administered twice/day,
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the frequency and severity of GI symptoms before and after switching to Bafiertam®.
The GI tolerability of Bafiertam® following a switch from dimethyl fumarate will be assessed by determining the frequency and severity of GI events using a modified gastrointestinal symptom scale.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start30 Jun 2021 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion29 Sep 2022 (estimated)
Why it stopped: Business considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas W Lategan, D.Phil., Study director, Banner Life Sciences LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925778
- Sponsor's protocol ID
- BLS-11-403
- Acronym
- PERSIST
- Status last verified
- Nov 2021
- First submitted
- 8 Jun 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® (Monomethyl Fumarate) From Dimethyl Fumarate (PERSIST)
- ClinicalTrials.gov ID
- NCT04925778
- Acronym / sponsor ID
- PERSIST / BLS-11-403
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Bafiertam, Tecfidera, dimethyl fumarate, monomethyl fumarate, gastrointestinal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Banner Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 29 Sep 2022 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam®.
Detailed description
This is an open-label, multicenter, observational study evaluating GI symptoms in relapsing-remitting multiple sclerosis (RRMS) patients who switch from dimethyl fumarate (DMF) to Bafiertam® (monomethyl fumarate).
Adult patients with a diagnosis of RRMS receiving continuous treatment with DMF monotherapy and who are experiencing GI symptoms will be eligible to enroll in the study.
Patients will be identified and screened by chart review and invited to report GI Symptoms for one baseline week using a study app downloaded on their own smartphone/tablet. During this week, patients will continue their currently prescribed and remaining DMF treatment and will record their GI symptoms daily using the app.
At the end of the Baseline Period, patients will be asked to cease administration of the DMF, and to commence self-treatment with Bafiertam® 95 mg capsules twice a day (total daily dose of 380 mg) approximately 12 hours apart the following day for 28 days. They will be required to continue to record their GI symptoms each day.
On Day 28; End-of Study [EOS]) the patient's diary will be reviewed, adverse events (AE) recorded, and drug accountability performed.
Following EOS patients will be asked if they wish to continue Bafiertam® treatment. Those patients who elect to continue will be contacted one month and two months after EOS to ascertain if they remain on Bafiertam®.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis currently treated with dimethyl fumarate (DMF), and experiencing gastrointestinal symptoms attributable to DMF are eligible. Sufficient patients will be enrolled until 50 evaluable patients complete the study.
Key inclusion criteria (6 listed)
- Male or non-pregnant female aged 18years and older.
- Diagnosis of RRMS (per McDonald 2010 Criteria) at screening [Polman 2011].
- Currently being treated with dimethyl fumarate (DMF; Tecfidera® or generic equivalent). At least 1 week and 1 day of continuous treatment with DMF monotherapy prior to initiation of Bafiertam®. Note: continuous treatment with DMF is defined as treatment uninterrupted by other disease-modifying treatment.
- GI symptoms (defined as any combination of abdominal pain, nausea, vomiting, diarrhea, constipation, bloating, or flatulence) while receiving treatment with DMF.
- Must be naïve to Bafiertam®.
Key exclusion criteria (7 listed)
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014].
- Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
- History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient (monomethyl fumarate), dimethyl fumarate, diroximel fumarate (Vumerity®), or any of the excipients.
- Lymphocyte counts less than 1000/microliter. Any other clinically significant abnormalities in CBC, blood and urine chemistries, or liver function tests in the past 30 days.
- History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML) and herpes zoster) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
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 |
|---|---|---|
| monomethyl fumarateAlso: Bafiertam®, BLS-11Patients will be prescribed 190 mg (two 95 mg capsules) self-administered twice/day, | Drug | – |
Primary outcome
Comparison of the frequency and severity of GI symptoms before and after switching to Bafiertam®.
Time frame: 28 days
The GI tolerability of Bafiertam® following a switch from dimethyl fumarate will be assessed by determining the frequency and severity of GI events using a modified gastrointestinal symptom scale.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Thomas W Lategan, D.Phil. study director
Banner Life Sciences LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparison of the frequency and severity of GI symptoms before and after switching to Bafiertam®. (time frame: 28 days). 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 18 Nov 2021.