Clinical trial NCT06402487: Propionic Acid in Multiple Sclerosis
Official title: Propionic Acid in Multiple Sclerosis - a Placebo-controlled Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Propionic Acid
Progression
Disability
Fatigue
Lead sponsor: Salzburger Landeskliniken
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum neurofilament light chain (NfL)
timeFrame: 90 days
measure: Serum glial fibrillary acid protein (GFAP)
timeFrame: 90 days
Secondary outcomes:
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: 90 days
measure: Walking test, 10 meters distance
timeFrame: 90 days
measure: cerebral MRI
timeFrame: 90 days
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 90 days
measure: Magnetoencephalography (MEG)
timeFrame: 90 days
measure: 9-hole peg test
timeFrame: 90 days
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
Study officials:
References:
citation: Duscha A, Gisevius B, Hirschberg S, Yissachar N, Stangl GI, Dawin E, Bader V, Haase S, Kaisler J, David C, Schneider R, Troisi R, Zent D, Hegelmaier T, Dokalis N, Gerstein S, Del Mare-Roumani S, Amidror S, Staszewski O, Poschmann G, Stuhler K, Hirche F, Balogh A, Kempa S, Trager P, Zaiss MM, Holm JB, Massa MG, Nielsen HB, Faissner A, Lukas C, Gatermann SG, Scholz M, Przuntek H, Prinz M, Forslund SK, Winklhofer KF, Muller DN, Linker RA, Gold R, Haghikia A. Propionic Acid Shapes the Multiple Sclerosis Disease Course by an Immunomodulatory Mechanism. Cell. 2020 Mar 19;180(6):1067-1080.e16. doi: 10.1016/j.cell.2020.02.035. Epub 2020 Mar 10.