Status:
TERMINATED
Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
Lead Sponsor:
Banner Life Sciences LLC
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- Male or non-pregnant female aged 18 years and older.
- Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
- Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
- Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.
- Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
- Willing and able to complete all the study procedures and communicate meaningfully with study personnel.
Exclusion
- Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
- Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05978531
Start Date
August 17 2023
End Date
February 24 2025
Last Update
March 6 2025
Active Locations (10)
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1
Gilbert Neurology
Gilbert, Arizona, United States, 85297
2
Center for Neurology and Spine
Phoenix, Arizona, United States, 85032
3
Perseverance Research Center, LLC
Scottsdale, Arizona, United States, 85253
4
Clinical Endpoints
Scottsdale, Arizona, United States, 85258