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Completed

NCT Number: NCT06402487

Propionic Acid in Multiple Sclerosis

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Disease Progression Fatigue Immune System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Salzburger Landeskliniken

Salzburg, State of Salzburg, 5020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propionic acid 1000 mg capsule

Dietary Supplement

Patients will be assigned to propionic acid or placebo as add on MS treatment.

Placebo

Dietary Supplement

Patients will be assigned to propionic acid or placebo as add on MS treatment.

Primary outcomes

  1. Serum neurofilament light chain (NfL)

    Time frame: 90 days

    assessed as pg/ml

  2. Serum glial fibrillary acid protein (GFAP)

    Time frame: 90 days

    assessed as pg/ml

Secondary outcomes

  1. Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Time frame: 90 days

    Fatigue Score, Questionnaire

  2. Walking test, 10 meters distance

    Time frame: 90 days

    assessed as seconds

  3. cerebral MRI

    Time frame: 90 days

    number of rim lesions; subgroup analysis

  4. 36-Item Short Form Health Survey (SF-36)

    Time frame: 90 days

    Quality of Life, Questionnaire

  5. Magnetoencephalography (MEG)

    Time frame: 90 days

    Assessing neuronal slowing proposed as a marker of cognitive impairment in MS; Subgroup analysis

  6. 9-hole peg test

    Time frame: 90 days

    assessed in seconds

Sponsors and collaborators

Lead sponsor

Salzburger Landeskliniken

Other

Registry information

Official study title

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

Acronym: MADAI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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