Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Propionic Acid, Drug Safety, Cognitive Performance, Disability
Brief 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).
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 cognitive testing (SDMT), physical performance (9HPT, 10mWT), patient-reported outcome measurements PROMs (SF-36, FSMC, ESS, BDI-II), and serum NfL analysis.
Interventions
DIETARY_SUPPLEMENTPropionic acid 1000 mg capsule
Patients will receive propionic acid as add on MS treatment.
Sponsors
Salzburger Landeskliniken
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum neurofilament light chain (NfL) | 9 months | assessed as pg/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symbol Digit Modalities Test (SDMT) | 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. |
| Nine-Hole Peg Test (9HPT) | 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. |
| 10-Meter Walk Test (10mWT) | 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. |
| Short Form Health Survey (SF-36) | 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). |
| Fatigue Scale for Motor and Cognitive Functions (FSMC) | 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). |
| Epworth Sleepiness Scale (ESS) | 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). |
| Beck Depression Inventory-II (BDI-II) | 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). |
Countries
Austria
Outcome results
None listed