Multiple SclerosisPhase 2/3MADAINCT06402487
Propionic Acid in Multiple Sclerosis
A Phase 2/3 study testing Propionic acid 1000 mg capsule in people with Multiple Sclerosis, run by Salzburger Landeskliniken at 1 site in Austria.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Propionic acid 1000 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2024to 9 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Propionic acid 1000 mg capsule, Placebo
- Keywords
- Multiple Sclerosis, Propionic Acid, Progression, Disability, Fatigue
- Medical subject headings
- Multiple Sclerosis, Disease Progression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propionic acid 1000 mg capsuleDietary supplement
Patients will be assigned to propionic acid or placebo as add on MS treatment.
PlaceboDietary supplement
Patients will be assigned to propionic acid or placebo as add on MS treatment.
| Study group | Role | What they receive |
|---|---|---|
| Propionic acid 1000 mg | Active comparator | Not described Receives: Dietary Supplement: Propionic acid 1000 mg capsule |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum neurofilament light chain (NfL)
assessed as pg/ml
Measured: 90 days
Serum glial fibrillary acid protein (GFAP)
assessed as pg/ml
Measured: 90 days
Secondary outcomes (6)
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Fatigue Score, Questionnaire
Measured: 90 days
Walking test, 10 meters distance
assessed as seconds
Measured: 90 days
cerebral MRI
number of rim lesions; subgroup analysis
Measured: 90 days
36-Item Short Form Health Survey (SF-36)
Quality of Life, Questionnaire
Measured: 90 days
Magnetoencephalography (MEG)
Assessing neuronal slowing proposed as a marker of cognitive impairment in MS; Subgroup analysis
Measured: 90 days
9-hole peg test
assessed in seconds
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2024
- Primary completion15 Sep 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Moser, Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402487
- Sponsor's protocol ID
- 1026/2024
- Acronym
- MADAI
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32160527Lerda-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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propionic Acid in Multiple Sclerosis - a Placebo-controlled Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06402487
- Acronym / sponsor ID
- MADAI / 1026/2024
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Propionic Acid, Progression, Disability, Fatigue
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (MS).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propionic acid 1000 mg | Active comparator | Dietary Supplement: Propionic acid 1000 mg capsule |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propionic acid 1000 mg capsulePatients will be assigned to propionic acid or placebo as add on MS treatment. | Dietary supplement | Propionic acid 1000 mg |
| PlaceboPatients will be assigned to propionic acid or placebo as add on MS treatment. | Dietary supplement | Placebo |
Primary outcome
Serum neurofilament light chain (NfL)
Time frame: 90 days
assessed as pg/ml
Serum glial fibrillary acid protein (GFAP)
Time frame: 90 days
assessed as pg/ml
6 secondary outcomes
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time frame: 90 days
Walking test, 10 meters distance
Time frame: 90 days
cerebral MRI
Time frame: 90 days
36-Item Short Form Health Survey (SF-36)
Time frame: 90 days
Magnetoencephalography (MEG)
Time frame: 90 days
9-hole peg test
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 32160527Duscha 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.
- Derived from this study: PubMed 41780143Lerda-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propionic acid 1000 mg capsule in people with Multiple Sclerosis, run by Salzburger Landeskliniken at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum neurofilament light chain (NfL) (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402487, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.