NCT05978531

Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice

A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Banner Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Monomethyl Fumarate	95 mg oral capsule, 190 mg (2 x 95 mg) twice daily

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2023-08-07
• Last updated: 2025-03-06

Locations

10 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study