Propionic Acid in Multiple Sclerosis (MADAI)

October 10, 2024 updated by: Tobias Moser, Salzburger Landeskliniken

Propionic Acid in Multiple Sclerosis - a Placebo-controlled Randomized Double-blinded Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Salzburger Landeskliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Patients will be assigned to propionic acid or placebo as add on MS treatment.
Active Comparator: Propionic acid 1000 mg
Dietary supplement: Propionic acid 1000 mg capsule
Patients will be assigned to propionic acid or placebo as add on MS treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum neurofilament light chain (NfL)
Time Frame: 90 days
assessed as pg/ml
90 days
Serum glial fibrillary acid protein (GFAP)
Time Frame: 90 days
assessed as pg/ml
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time Frame: 90 days
Fatigue Score, Questionnaire
90 days
Walking test, 10 meters distance
Time Frame: 90 days
assessed as seconds
90 days
cerebral MRI
Time Frame: 90 days
number of rim lesions; subgroup analysis
90 days
36-Item Short Form Health Survey (SF-36)
Time Frame: 90 days
Quality of Life, Questionnaire
90 days
Magnetoencephalography (MEG)
Time Frame: 90 days
Assessing neuronal slowing proposed as a marker of cognitive impairment in MS; Subgroup analysis
90 days
9-hole peg test
Time Frame: 90 days
assessed in seconds
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salzburger Landeskliniken

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

October 9, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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