NCT05978531

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
2 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 17, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

July 25, 2023

Last Update Submit

March 4, 2025

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants on treatment with Bafiertam at 1 Year.

    Percentage of participants on treatment with Bafiertam at 1 Year.

    12 months

Secondary Outcomes (3)

  • Percentage of Participants on Treatment with Bafiertam at 6 months

    6 months

  • Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    12 months

  • Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.

    12 months

Interventions

Monomethyl FumarateDRUG

95 mg oral capsule, 190 mg (2 x 95 mg) twice daily

Also known as: Bafiertam, BLS-11

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be selected from existing patients known to the individual investigators.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Gilbert Neurology

Gilbert, Arizona, 85297, United States

Location

Center for Neurology and Spine

Phoenix, Arizona, 85032, United States

Location

Perseverance Research Center, LLC

Scottsdale, Arizona, 85253, United States

Location

Clinical Endpoints

Scottsdale, Arizona, 85258, United States

Location

Regina Berkovich MD PhD Inc.

West Hollywood, California, 90048, United States

Location

Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

Maryland Center for Neurology and Sleep

Glen Burnie, Maryland, 21061, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Caribbean Center for Clinical Research/San Juan MS Center

San Juan, Puerto Rico

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

monomethyl fumarate

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Thomas Lategan, PhD

    Banner Life Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 7, 2023

Study Start

August 17, 2023

Primary Completion

February 24, 2025

Study Completion

February 24, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(9)PR(1)