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A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.
This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.
Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic conversion after oral administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Gilbert Neurology
Gilbert, Arizona, United States
Center for Neurology and Spine
Phoenix, Arizona, United States
Perseverance Research Center, LLC
Scottsdale, Arizona, United States
Clinical Endpoints
Scottsdale, Arizona, United States
Regina Berkovich MD PhD Inc.
West Hollywood, California, United States
Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Maryland Center for Neurology and Sleep
Glen Burnie, Maryland, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Caribbean Center for Clinical Research/San Juan MS Center
San Juan, Puerto Rico
Start Date
August 17, 2023
Primary Completion Date
February 24, 2025
Completion Date
February 24, 2025
Last Updated
March 6, 2025
25
ACTUAL participants
Monomethyl Fumarate
DRUG
Lead Sponsor
Banner Life Sciences LLC
NCT04047628
NCT04602390
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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