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Propionic Acid for Multiple Sclerosis: Safety and Benefits (Pro-MADAI)

12. maj 2026 opdateret af: Tobias Moser, Salzburger Landeskliniken

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

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Østrig
    • State of Salzburg
      • Salzburg, State of Salzburg, Østrig, 5020
        • Salzburger Landeskliniken

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Propionsyre 1000 mg
Kosttilskud: Propionic acid 1000 mg capsule
Patients will receive propionic acid as add on MS treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum neurofilament light chain (NfL)
Tidsramme: 9 months
assessed as pg/ml
9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symbol Digit Modalities Test (SDMT)
Tidsramme: 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.
9 months
Nine-Hole Peg Test (9HPT)
Tidsramme: 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.
9 months
10-Meter Walk Test (10mWT)
Tidsramme: 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.
9 months
Short Form Health Survey (SF-36)
Tidsramme: 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).
9 months
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Tidsramme: 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).
9 months
Epworth Sleepiness Scale (ESS)
Tidsramme: 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).
9 months
Beck Depression Inventory-II (BDI-II)
Tidsramme: 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).
9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Salzburger Landeskliniken

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2024

Primær færdiggørelse (Faktiske)

1. maj 2025

Studieafslutning (Faktiske)

12. december 2025

Datoer for studieregistrering

Først indsendt

3. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1026/2024-2

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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