PERSIST
What it found
The trial ended early for another reason (see below).
Reason given: Business considerations
What was tested
Treatment tested
- Monomethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
Comparison of the frequency and severity of GI symptoms before and after switching to Bafiertam®.
28 days
Safety
Who could take part
Relapsing MS · 18 and over
Key Inclusion Criteria: 1. Male or non-pregnant female aged 18years and older. 2. Diagnosis of RRMS (per McDonald 2010 Criteria) at screening [Polman 2011]. 3. 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. 4. GI symptoms (defined as any combination of abdominal pain, nausea, vomiting, diarrhea, constipation, bloating, or flatulence) while receiving treatment with DMF. 5. Must be naïve to Bafiertam®. 6. Additional inclusion criteria apply Key Exclusion Criteria: 1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) [Lublin 2014]. 2. Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening. 3. 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. 4. 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. 5. 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. 6. Any prior suspicion of PML. 9. Additional exclusion criteria apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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®.
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History
Started
Jun 2021
Main results due
Aug 2022
Finished
Sept 2022
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