NCT07595081

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 multiple-sclerosis

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 3, 2026

Last Update Submit

May 12, 2026

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisPropionic AcidDrug SafetyCognitive PerformanceDisability

Outcome Measures

Primary Outcomes (1)

  • Serum neurofilament light chain (NfL)

    assessed as pg/ml

    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

  • +2 more secondary outcomes

Study Arms (1)

Propionic acid 1000 mg

ACTIVE COMPARATOR
Dietary Supplement: Propionic acid 1000 mg capsule

Interventions

Propionic acid 1000 mg capsuleDIETARY_SUPPLEMENT

Patients will receive propionic acid as add on MS treatment.

Propionic acid 1000 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salzburger Landeskliniken

Salzburg, State of Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

propionic acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
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

May 19, 2026

Record last verified: 2026-05

Locations

AU(1)