Propionic Acid in Multiple Sclerosis

NCT ID: NCT06402487

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-10-09

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Propionic acid 1000 mg

Group Type: ACTIVE_COMPARATOR

Propionic acid 1000 mg capsule

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Propionic acid 1000 mg capsule

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salzburger Landeskliniken

OTHER

Sponsor Role: lead

Responsible Party

Tobias Moser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Salzburger Landeskliniken

Salzburg, Salzburg, Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 32160527 (View on PubMed)

Other Identifiers

1026/2024

Identifier Type: -

Identifier Source: org_study_id