Propionic Acid for Multiple Sclerosis: Safety and Benefits (Pro-MADAI)

Salzburger Landeskliniken

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Sclerosis

Treatments: Dietary Supplement: Propionic acid 1000 mg capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT07595081

1026/2024-2

Details and patient eligibility

About

The 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).

Full description

This study is a prospective, open-label extension of the placebo-controlled MADAI trial, including 22 patients with stable relapsing-remitting multiple sclerosis. Participants received oral PA (500 mg twice daily) for an additional 9 months follow-up (FU). Multimodal assessments included cognitive testing (SDMT), physical performance (9HPT, 10mWT), patient-reported outcome measurements PROMs (SF-36, FSMC, ESS, BDI-II), and serum NfL analysis.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 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 70 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

• History of ongoing propionic acid (PA) supplementation exceeding 3 months
• Positive JC virus titer during natalizumab treatment
• Presence of severe active systemic disease
• Presence of acute neurological conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Propionic acid 1000 mg

Active Comparator group

Treatment:

Dietary Supplement: Propionic acid 1000 mg capsule