Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
Stopped early
Conditions studied: Relapsing Remitting Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05978531
- Run by
- Banner Life Sciences LLC
- People needed
- 25
- Starts
- 2023-08-17
- Expected to finish
- 2025-02-24
- Last updated by the study team
- 2025-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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