Propionic Acid in Multiple Sclerosis (MADAI)

Salzburger Landeskliniken

Status and phase

Completed

Phase 3

Phase 2

Conditions

Multiple Sclerosis

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Propionic acid 1000 mg capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT06402487

1026/2024

Details and patient eligibility

About

The purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (MS).

Full 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.

Enrollment

101 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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