Long-term Safety and Tolerability of Propionic Acid in MS Patients
A study aimed to explore the long-term safety and tolerability of propionic acid (1000 mg) as an add-on treatment in patients with stable relapsing-remitting multiple sclerosis. Participants took the supplement for an additional 9 months after a preliminary trial, with observations made concerning treatment-emergent adverse events.
- Tags
- #Other
- Most relevant to
- —
- Source
- Read original source
Why it matters
Understanding the safety profile and tolerability of new treatments like propionic acid is crucial for improving care in MS. However, findings are pending, limiting current implications.
What this does not prove
No results have been posted, and the planned endpoints do not provide findings. Thus, we cannot ascertain efficacy or definitive safety implications.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Other
Original sources
- Trial registrationPropionic Acid for Multiple Sclerosis: Safety and Benefits ↗
Supporting passages (12)
study phaseThe purpose of this study is to explore the long-term safety, tolerability, and clinical efficacy of propionic acid as an add-on therapy in multiple sclerosis (MS).
study design"detailedDescription": "This study is a prospective, open-label extension of the placebo-controlled MADAI trial, including 22 patients with stable relapsing-remitting multiple sclerosis.
subjectsincluding 22 patients with stable relapsing-remitting multiple sclerosis.
randomized"allocation": "NON_RANDOMIZED",
controlled"type": "ACTIVE_COMPARATOR",
research categories"interventionModel": "SINGLE_GROUP",
relevant ms types"eligibilityCriteria": "Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis (MS)\n* Clinically and radiologically stable MS in the previous 3 months\n* Age between 18 and 70 years\n* Positive finding for oligoclonal bands (OCBs)\n* Written consent\n* Blood collection at the beginning and end of the study for routine parameter examination as well as sample preservation (especially for measuring propionic acid levels)\n* Negative pregnancy test for female participants of childbearing age\n\nExclusion Criteria:\n\n* History of ongoing propionic acid (PA) supplementation exceeding 3 months\n* Positive JC virus titer during natalizumab treatment\n* Presence of severe active systemic disease\n* Presence of acute neurological conditions",
interventionParticipants received oral PA (500 mg twice daily) for an additional 9 months follow-up (FU).
comparatorParticipants who received no further PA supplementation are identified through routine clinical follow-up after completion of the MADAI trial.
primary endpoint"description": "Treatment-Emergent Adverse Events\n\nNumber of participants experiencing at least one treatment-emergent adverse event during the study, as assessed through participant reports, patient diaries, and routine laboratory assessments.",
findingsThe purpose of this study is to explore the long-term safety, tolerability, and clinical efficacy of propionic acid as an add-on therapy in multiple sclerosis (MS).
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.