Relapsing Remitting Multiple Sclerosis Clinical Trial
— PERSISTOfficial title:
An Open-label, Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® (Monomethyl Fumarate) From Dimethyl Fumarate (PERSIST)
NCT number | NCT04925778 |
Other study ID # | BLS-11-403 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2021 |
Est. completion date | September 29, 2022 |
Verified date | November 2021 |
Source | Banner Life Sciences LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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®.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 29, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Banner Life Sciences LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 28 days |
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