NCT06402487

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started May 2024

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2024

Completed
Last Updated

October 15, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 29, 2024

Last Update Submit

October 10, 2024

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisPropionic AcidProgressionDisabilityFatigue

Outcome Measures

Primary Outcomes (2)

  • Serum neurofilament light chain (NfL)

    assessed as pg/ml

    90 days

  • Serum glial fibrillary acid protein (GFAP)

    assessed as pg/ml

    90 days

Secondary Outcomes (6)

  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    90 days

  • Walking test, 10 meters distance

    90 days

  • cerebral MRI

    90 days

  • 36-Item Short Form Health Survey (SF-36)

    90 days

  • Magnetoencephalography (MEG)

    90 days

  • +1 more secondary outcomes

Study Arms (2)

Propionic acid 1000 mg

ACTIVE COMPARATOR
Dietary Supplement: Propionic acid 1000 mg capsule

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Propionic acid 1000 mg capsuleDIETARY_SUPPLEMENT

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

Propionic acid 1000 mg
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salzburger Landeskliniken

Salzburg, Salzburg, 5020, Austria

Location

Related Publications (1)

  • 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.

    PMID: 32160527BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisDisease ProgressionFatigue

Interventions

propionic acid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 7, 2024

Study Start

May 1, 2024

Primary Completion

September 15, 2024

Study Completion

October 9, 2024

Last Updated

October 15, 2024

Record last verified: 2024-05

Locations

AU(1)