Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate

NCT04925778 | Withdrawn FDA Drug

• 1 other identifier: BLS-11-403
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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®.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Bafiertam; Tecfidera; dimethyl fumarate; monomethyl fumarate; gastrointestinal

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

monomethyl fumarate DRUG

Patients will be prescribed 190 mg (two 95 mg capsules) self-administered twice/day,

Also known as: Bafiertam®, BLS-11

Eligibility Criteria

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

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.

You may qualify if:

• 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®.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Banner Life Sciences LLC: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

monomethyl fumarate

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

Study Officials

• Thomas W Lategan, D.Phil.

  Banner Life Sciences LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: June 30, 2021
• Primary Completion: August 30, 2022
• Study Completion: September 29, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share