Multiple SclerosisPro-MADAINCT07595081
Propionic Acid for Multiple Sclerosis: Safety and Benefits
A 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 explore the long-term safety, tolerability, and clinical efficacy of propionic acid as an add-on therapy in multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 70 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?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2024to 12 Dec 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
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 safety and tolerability, cognitive testing (SDMT), physical performance (9HPT, 10mWT), and patient-reported outcome measurements PROMs (SF-36, FSMC, ESS, BDI-II).
- Conditions
- Multiple Sclerosis
- Being tested
- Propionic acid 1000 mg capsule
- Keywords
- Multiple Sclerosis, Propionic Acid, Drug Safety, Cognitive Performance, Disability
- Medical subject headings
- Multiple Sclerosis
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 receive propionic acid as add on MS treatment.
| Study group | Role | What they receive |
|---|---|---|
| Propionic acid 1000 mg | Active comparator | Participants recruited from the MADAI trial receive oral PA 500 mg twice daily for an additional 9-month follow-up period. Receives: Dietary Supplement: Propionic acid 1000 mg capsule |
| Observational control cohort | No intervention | Participants who received no further PA supplementation are identified through routine clinical follow-up after completion of the MADAI trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Treatment-Emergent Adverse Events
Number of participants experiencing at least one treatment-emergent adverse event during the study, as assessed through participant reports, patient diaries, and routine laboratory assessments.
Measured: 9 months
Secondary outcomes (7)
Symbol Digit Modalities Test (SDMT)
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.
Measured: 9 months
Nine-Hole Peg Test (9HPT)
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.
Measured: 9 months
10-Meter Walk Test (10mWT)
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.
Measured: 9 months
Short Form Health Survey (SF-36)
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).
Measured: 9 months
Fatigue Scale for Motor and Cognitive Functions (FSMC)
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).
Measured: 9 months
Epworth Sleepiness Scale (ESS)
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).
Measured: 9 months
Beck Depression Inventory-II (BDI-II)
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).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Aug 2024
- Primary completion1 May 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT07595081
- Sponsor's protocol ID
- 1026/2024-2
- Acronym
- Pro-MADAI
- Status last verified
- Sep 2026
- First submitted
- 3 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moser T, Hitzl W, Lerda-Casaccia T, Unterhofer M, Demjaha R, Martinez-Serrat M, Khalil M, Harrer A, Bohm B, Hofbauer P, Cadamuro J, Huber-Schonauer U, Trinka E, Wipfler P. Propionic acid in multiple sclerosis: a phase 2b, double-blind, randomized placebo-controlled trial. Brain. 2026 Jul 6;149(7):2286-94. doi: 10.1093/brain/awag099. Online ahead of print.
PubMed 42402345
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propionic Acid in Multiple Sclerosis: Safety, Tolerability and Clinical Outcomes From the Pro-MADAI Study
- ClinicalTrials.gov ID
- NCT07595081
- Acronym / sponsor ID
- Pro-MADAI / 1026/2024-2
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Propionic Acid, Drug Safety, Cognitive Performance, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 19 May 2026 (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 explore the long-term safety, tolerability, and clinical efficacy of propionic acid as an add-on therapy in multiple sclerosis (MS).
Detailed description
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 safety and tolerability, cognitive testing (SDMT), physical performance (9HPT, 10mWT), and patient-reported outcome measurements PROMs (SF-36, FSMC, ESS, BDI-II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propionic acid 1000 mg | Active comparator | Dietary Supplement: Propionic acid 1000 mg capsuleParticipants recruited from the MADAI trial receive oral PA 500 mg twice daily for an additional 9-month follow-up period. |
| Observational control cohort | No intervention | –Participants who received no further PA supplementation are identified through routine clinical follow-up after completion of the MADAI trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 70 years
- Positive finding for oligoclonal bands (OCBs)
- Written consent
Key exclusion criteria (4 listed)
- 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
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 receive propionic acid as add on MS treatment. | Dietary supplement | Propionic acid 1000 mg |
Primary outcome
Safety and tolerability
Time frame: 9 months
Treatment-Emergent Adverse Events Number of participants experiencing at least one treatment-emergent adverse event during the study, as assessed through participant reports, patient diaries, and routine laboratory assessments.
7 secondary outcomes
Symbol Digit Modalities Test (SDMT)
Time frame: 9 months
Nine-Hole Peg Test (9HPT)
Time frame: 9 months
10-Meter Walk Test (10mWT)
Time frame: 9 months
Short Form Health Survey (SF-36)
Time frame: 9 months
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time frame: 9 months
Epworth Sleepiness Scale (ESS)
Time frame: 9 months
Beck Depression Inventory-II (BDI-II)
Time frame: 9 months
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 22 Sep 2026.
- Background: PubMed 42402345Moser T, Hitzl W, Lerda-Casaccia T, Unterhofer M, Demjaha R, Martinez-Serrat M, Khalil M, Harrer A, Bohm B, Hofbauer P, Cadamuro J, Huber-Schonauer U, Trinka E, Wipfler P. Propionic acid in multiple sclerosis: a phase 2b, double-blind, randomized placebo-controlled trial. Brain. 2026 Jul 6;149(7):2286-94. doi: 10.1093/brain/awag099. Online ahead of print.
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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 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 4 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 22 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Safety and tolerability (time frame: 9 months). 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 NCT07595081, which also lists 1 linked publication.
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 22 Sep 2026.