Propionic Acid for Multiple Sclerosis: Safety and Benefits

NCT07595081 | Completed

• 1 other identifier: 1026/2024-2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Propionic Acid; Drug Safety; Cognitive Performance; Disability

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Treatment-Emergent Adverse Events Number of participants experiencing at least one treatment-emergent adverse event during the study, as assessed through participant reports, patient diaries, and routine laboratory assessments.

  9 months

Secondary Outcomes (7)

• Symbol Digit Modalities Test (SDMT)

  9 months

• Nine-Hole Peg Test (9HPT)

  9 months

• 10-Meter Walk Test (10mWT)

  9 months

• Short Form Health Survey (SF-36)

  9 months

• Fatigue Scale for Motor and Cognitive Functions (FSMC)

  9 months

Study Arms (2)

Propionic acid 1000 mg

ACTIVE COMPARATOR

Participants recruited from the MADAI trial receive oral PA 500 mg twice daily for an additional 9-month follow-up period.

Dietary Supplement: Propionic acid 1000 mg capsule

Observational control cohort

NO INTERVENTION

Participants who received no further PA supplementation are identified through routine clinical follow-up after completion of the MADAI trial.

Interventions

Propionic acid 1000 mg capsule DIETARY_SUPPLEMENT

Patients will receive propionic acid as add on MS treatment.

Propionic acid 1000 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salzburger Landeskliniken: lead

Study Sites (1)

Salzburger Landeskliniken

Salzburg, State of Salzburg, 5020, Austria

Location

Related Publications (1)

• Moser T, Hitzl W, Lerda-Casaccia T, Unterhofer M, Demjaha R, Martinez-Serrat M, Khalil M, Harrer A, Bohm B, Hofbauer P, Cadamuro J, Huber-Schonauer U, Trinka E, Wipfler P. Propionic acid in multiple sclerosis: a phase 2b, double-blind, randomized placebo-controlled trial. Brain. 2026 Jul 6;149(7):2286-94. doi: 10.1093/brain/awag099. Online ahead of print.

  PMID: 42402345 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

propionic acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 19, 2026
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 12, 2025
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

AU (1)