Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Propionic Acid, Progression, Disability, Fatigue
Brief summary
The purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (MS).
Detailed description
This is a single-center, double-blinded, randomized trial. One hundred multiple sclerosis (MS) patients will be randomly assigned in a 2:1 ratio to receive either 100 mg of propionic acid or a placebo over a period of 90 days. Outcome measures will encompass NfL and GFAP levels, fatigue scores, quality of life assessments, and physical examinations. Additionally, subgroup analysis will involve the evaluation of MRI and MEG data.
Interventions
DIETARY_SUPPLEMENTPropionic acid 1000 mg capsule
Patients will be assigned to propionic acid or placebo as add on MS treatment.
DIETARY_SUPPLEMENTPlacebo
Patients will be assigned to propionic acid or placebo as add on MS treatment.
Sponsors
Salzburger Landeskliniken
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of multiple sclerosis (MS) * Clinically and radiologically stable MS in the previous 3 months * Age between 18 and 60 years * Positive finding for oligoclonal bands (OCBs) * Written consent * 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) * Negative pregnancy test for female participants of childbearing age
Exclusion criteria
* Existing propionic acid supplementation * Change in disease-modifying therapy (DMT) in the previous 4 weeks * Existing severe systemic diseases * Presence of other concomitant structural nerve diseases (e.g., polyneuropathy, brain tumor, strokes) * High JCV titer under Natalizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum neurofilament light chain (NfL) | 90 days | assessed as pg/ml |
| Serum glial fibrillary acid protein (GFAP) | 90 days | assessed as pg/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Scale for Motor and Cognitive Functions (FSMC) | 90 days | Fatigue Score, Questionnaire |
| Walking test, 10 meters distance | 90 days | assessed as seconds |
| cerebral MRI | 90 days | number of rim lesions; subgroup analysis |
| 36-Item Short Form Health Survey (SF-36) | 90 days | Quality of Life, Questionnaire |
| Magnetoencephalography (MEG) | 90 days | Assessing neuronal slowing proposed as a marker of cognitive impairment in MS; Subgroup analysis |
| 9-hole peg test | 90 days | assessed in seconds |
Countries
Austria
Outcome results
None listed