ClinicalTrials.gg
CompletedNCT06402487MADAIUpdated Sep 15, 2026

Propionic Acid in Multiple Sclerosis

A Phase 2/3 interventional study of Propionic acid 1000 mg capsule and Placebo in Multiple Sclerosis, sponsored by Salzburger Landeskliniken. Completed at 1 site in Austria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Salzburger Landeskliniken · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 78 studies in Multiple Sclerosis with a site in Austria — 2 open to participants now, 10 under way, 7 of them phase 3. Multiple Sclerosis · Austria.

Enrollment
55th of 63
101 · median 534
Started
2024
with 3 others
Phase 2/3
Only one
of the 78
Registered
72nd of 78
by date

Among the 78 studies in Multiple Sclerosis with a site in Austria, this one is the 55th largest by enrollment of the 63 interventional ones that give a count, is one of 4 that started in 2024, is the only one in phase 2/3, and was the 72nd registered.

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's enrollment of 101 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Open to participants now

2 of the 78 studies in Multiple Sclerosis with a site in Austria are open now.

All 2 open studies →

A study can be open while its sites in Austria have not opened yet or have stopped. Only those recruiting at a site in Austria →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 78 studies in Multiple Sclerosis with a site in Austria, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Propionic Acid
  • Progression
  • Disability
  • Fatigue
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
101 participants (actual)

Study arms

  • Active comparator
    Propionic acid 1000 mg

    Dietary Supplement: Propionic acid 1000 mg capsule

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementPropionic acid 1000 mg capsule

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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Serum neurofilament light chain (NfL)

    assessed as pg/ml

    Time frame: 90 days

  2. Serum glial fibrillary acid protein (GFAP)

    assessed as pg/ml

    Time frame: 90 days

Secondary outcomes

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

    Fatigue Score, Questionnaire

    Time frame: 90 days

  2. Walking test, 10 meters distance

    assessed as seconds

    Time frame: 90 days

  3. cerebral MRI

    number of rim lesions; subgroup analysis

    Time frame: 90 days

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

    Quality of Life, Questionnaire

    Time frame: 90 days

  5. Magnetoencephalography (MEG)

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

    Time frame: 90 days

  6. 9-hole peg test

    assessed in seconds

    Time frame: 90 days

07

Study locations

1 site
  • Salzburger Landeskliniken
    Salzburg, State of Salzburg 5020, Austria
08

References and documents

Publications

  • Duscha A, Gisevius B, Hirschberg S, Yissachar N, Stangl GI, Dawin E, Bader V, Haase S, Kaisler J, David C, Schneider R, Troisi R, Zent D, Hegelmaier T, Dokalis N, Gerstein S, Del Mare-Roumani S, Amidror S, Staszewski O, Poschmann G, Stuhler K, Hirche F, Balogh A, Kempa S, Trager P, Zaiss MM, Holm JB, Massa MG, Nielsen HB, Faissner A, Lukas C, Gatermann SG, Scholz M, Przuntek H, Prinz M, Forslund SK, Winklhofer KF, Muller DN, Linker RA, Gold R, Haghikia A. Propionic Acid Shapes the Multiple Sclerosis Disease Course by an Immunomodulatory Mechanism. Cell. 2020 Mar 19;180(6):1067-1080.e16. doi: 10.1016/j.cell.2020.02.035. Epub 2020 Mar 10. PubMed 32160527 ↗
  • Lerda-Casaccia T, Mitterwallner JM, Hitzl W, Bohm B, Cadamuro J, Huber-Schonauer U, Weichsler M, Radlberger RF, Wipfler P, Moser T. Association of lifestyle and metabolic factors with clinical performance in multiple sclerosis: A cross-sectional study. Med Clin (Barc). 2026 Apr;166(4):107358. doi: 10.1016/j.medcli.2026.107358. Epub 2026 Mar 3. English, Spanish. PubMed 41780143 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2024 to primary completion in Sep 2024, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2024
First posted
May 7, 2024
StartActual
May 1, 2024
Primary completionActual
Sep 15, 2024
CompletionActual
Oct 9, 2024
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06402487
Lead sponsor
Salzburger Landeskliniken
Responsible party
Tobias Moser (Principal Investigator, Salzburger Landeskliniken) — Principal investigator
First posted
May 7, 2024
Start date
May 1, 2024
Primary completion
Sep 15, 2024
Completion
Oct 9, 2024
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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