Relapsing Remitting Multiple SclerosisSIMPLENCT05978531
Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
An observational study of Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Monomethyl Fumarate
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 17 Aug 2023to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from existing patients known to the individual investigators.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Gilbert Neurology
Gilbert, Arizona, 85297
Maryland Center for Neurology and Sleep
Glen Burnie, Maryland, 21061
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Center for Neurology and Spine
Phoenix, Arizona, 85032
Perseverance Research Center, LLC
Scottsdale, Arizona, 85253
Clinical Endpoints
Scottsdale, Arizona, 85258
Holy Name Medical Center
Teaneck, New Jersey, 07666
Regina Berkovich MD PhD Inc.
West Hollywood, California, 90048
Puerto Rico1 site
Caribbean Center for Clinical Research/San Juan MS Center
San Juan
About this study
Official title: A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.
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.
Read the 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 administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Monomethyl Fumarate
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monomethyl FumarateDrug
Also called Bafiertam, BLS-11
95 mg oral capsule, 190 mg (2 x 95 mg) twice daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants on treatment with Bafiertam at 1 Year.
Percentage of participants on treatment with Bafiertam at 1 Year.
Measured: 12 months
Secondary outcomes (3)
Percentage of Participants on Treatment with Bafiertam at 6 months
Percentage of Participants on Treatment with Bafiertam at 6 months
Measured: 6 months
Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score (range 0 - 100) at Month 6 and 12 months.TSQM Version 9 is comprised of 9 questions that provide scores on four scales: effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). The scale scores are transformed and range from 0 to 100. Higher scores indicate greater satisfaction.
Measured: 12 months
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.
Number of Participants with AEs Leading to Treatment Discontinuation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start17 Aug 2023
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lategan, PhD, Study director, Banner Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978531
- Sponsor's protocol ID
- BLS-11-404
- Acronym
- SIMPLE
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.
- ClinicalTrials.gov ID
- NCT05978531
- Acronym / sponsor ID
- SIMPLE / BLS-11-404
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Banner Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from existing patients known to the individual investigators.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monomethyl FumarateAlso: Bafiertam, BLS-1195 mg oral capsule, 190 mg (2 x 95 mg) twice daily | Drug | – |
Primary outcome
Percentage of participants on treatment with Bafiertam at 1 Year.
Time frame: 12 months
Percentage of participants on treatment with Bafiertam at 1 Year.
3 secondary outcomes
Percentage of Participants on Treatment with Bafiertam at 6 months
Time frame: 6 months
Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time frame: 12 months
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lategan, PhD study director
Banner Life Sciences
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Banner Life Sciences LLC at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants on treatment with Bafiertam at 1 Year. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.