Stopped earlyRelapsing MSNCT05978531

What it found

Stopped early

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

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

    1. Started

      Aug 2023

    2. Main results due

      Feb 2025

    3. Finished

      Feb 2025

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