Propionic Acid in Multiple Sclerosis - a Placebo-controlled Randomized Double-blinded Clinical Trial

CompletedPhase 2Phase 3MS (type not specified)NCT06402487

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“The adjusted mean difference in sNfL levels between the PA and placebo groups at follow-up was 0.91 pg/ml (95% CI 0.02 to 1.79; P = 0.045).”
Read by software from the paper's abstract

90 days

adjusted mean difference 0.91 pg/ml (95% CI 0.02–1.79)

p = 0.045

Total participants: 101

Read by software from the paper's abstract

What was tested

Treatment tested

  • Propionic acid

Placebo

  • Placebo

What it measured

Main measures

  • Serum neurofilament light chain (NfL)

    90 days

    Blood or spinal fluid markers
  • Serum glial fibrillary acid protein (GFAP)

    90 days

    Blood or spinal fluid markers

Other measures (6)

  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    90 days

    Thinking and memoryFatigue
  • Walking test, 10 meters distance

    90 days

    Walking and mobility
  • cerebral MRI

    90 days

    MRI lesionsSmouldering inflammation
  • 36-Item Short Form Health Survey (SF-36)

    90 days

    Quality of life (reported by participants)
  • Magnetoencephalography (MEG)

    90 days

    Thinking and memory
  • 9-hole peg test

    90 days

    Disability progression

Who could take part

MS (type not specified) · 18 to 60

Show the full criteria

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

* 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      May 2024

    2. Main results due

      Sept 2024

    3. Finished

      Oct 2024

    Assembled by software from public sources.