SIMPLE
What it found
The trial ended early for another reason (see below).
Reason given: Business decision
This trial finished 20 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Monomethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
Percentage of participants on treatment with Bafiertam at 1 Year.
12 months
Other measures (3)
Percentage of Participants on Treatment with Bafiertam at 6 months
6 months
Treatment Satisfaction Questionnaire for Medication (TSQM-9)
12 months
Quality of life (reported by participants)Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.
12 months
Safety
Who could take part
Relapsing MS · 18 and over
Inclusion Criteria: 1. Male or non-pregnant female aged 18 years and older. 2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling. 3. Participants may enroll if they are within 90 days of initiating therapy with Bafiertam. 4. 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. 5. Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB). 6. Willing and able to complete all the study procedures and communicate meaningfully with study personnel. Exclusion Criteria: 1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam. 2. 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Aug 2023
Main results due
Feb 2025
Finished
Feb 2025
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