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Completed

NCT Number: NCT07595081

Propionic Acid for Multiple Sclerosis: Safety and Benefits

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).

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Key information

Age range

18 year–70 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 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.

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 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

Treatment and study plan

Propionic acid 1000 mg capsule

Dietary Supplement

Patients will receive propionic acid as add on MS treatment.

Primary outcomes

  1. Serum neurofilament light chain (NfL)

    Time frame: 9 months

    assessed as pg/ml

Secondary outcomes

  1. Symbol Digit Modalities Test (SDMT)

    Time frame: 9 months

    Measuring cognitive processing speed in patients with MS. Participants are instructed to match symbols to their respective numbers using a reference key. The final score is determined by the number of correct symbol-number pairings completed within 90 seconds. Higher scores indicate better cognitive abilities.

  2. Nine-Hole Peg Test (9HPT)

    Time frame: 9 months

    Instrument to evaluate fine motor skills of the upper limbs and manual dexterity. Performance is quantified by completion time, with shorter times reflecting better manual dexterity. The participants insert and remove nine small pegs individually into nine corresponding holes on a rectangular board. To improve reliability, this process was repeated twice for each hand.

  3. 10-Meter Walk Test (10mWT)

    Time frame: 9 months

    Evaluation of lower extremity function. Participants were instructed to walk in a straight line at their fastest comfortable pace without running. To avoid measurement bias caused by acceleration and deceleration phases, timing was restricted to the interval between the 2- and 8-meter marks, calculating walking speed over a 6-meter distance.

  4. Short Form Health Survey (SF-36)

    Time frame: 9 months

    The SF-36 covers eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). These are transformed into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both scores are calculated by combining the subscales using specific algorithms. They reflect the overall physical and mental health status, respectively. Each SF-36 domain is scored individually and transformed to a 0-100 scale, where 0 indicates poor health, and 100 represents optimal health. Scores are interpreted as follows: excellent (>60), above average (51-60), average to slightly below average (41-50), moderately below average (31-40), and significant impairment (<30).

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

    Time frame: 9 months

    Fatigue was assessed using the 20-item Fatigue Scale for Motor and Cognitive Functions (FSMC). Motor (FSMCmot) and cognitive (FSMCcog) aspects of fatigue were evaluated separately, and a total score (FSMCtot) was calculated. This score ranges from 20 to 100. Fatigue severity was classified as mild (≥43), moderate (≥53), or severe (≥63).

  6. Epworth Sleepiness Scale (ESS)

    Time frame: 9 months

    Daytime sleepiness was evaluated using the Epworth sleepiness scale (ESS), an 8-item self-report questionnaire. The ESS assesses the propensity to fall asleep or doze off briefly in different daily situations. Higher scores indicate greater daytime sleepiness. Each Item describes a hypothetical scenario, which participants rate on a 4-point scale (0-3). This results in a total score ranging from 0 to 24 points. Excessive daytime sleepiness was classified as mild (>10), moderate (>13), or severe (>16).

  7. Beck Depression Inventory-II (BDI-II)

    Time frame: 9 months

    Depressive symptoms were assessed using the Beck Depression Inventory-Second Edition (BDI-II), a 21-item questionnaire. It evaluates various aspects of depression, including libido, fatigue, appetite, decision-making ability, and feelings of guilt. For each item, participants were asked to select one of four statements assessing symptom severity from absent (0) to severe (3).

Sponsors and collaborators

Lead sponsor

Salzburger Landeskliniken

Other

Registry information

Official study title

Propionic Acid in Multiple Sclerosis: Safety, Tolerability and Clinical Outcomes From the Pro-MADAI Study

Acronym: Pro-MADAI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 19, 2026
Registry last updated
May 19, 2026

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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