Propionic Acid in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MADAI  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06402487
• Other study ID #: 1026/2024
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: May 1, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Salzburger Landeskliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• Propionic acid 1000 mg capsule
Patients will be assigned to propionic acid or placebo as add on MS treatment.
• Placebo
Patients will be assigned to propionic acid or placebo as add on MS treatment.

Locations

Country	Name	City	State
Austria	Salzburger Landeskliniken	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Salzburger Landeskliniken

Country where clinical trial is conducted

Austria, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum neurofilament light chain (NfL)	assessed as pg/ml	90 days
Primary	Serum glial fibrillary acid protein (GFAP)	assessed as pg/ml	90 days
Secondary	Fatigue Scale for Motor and Cognitive Functions (FSMC)	Fatigue Score, Questionnaire	90 days
Secondary	Walking test, 10 meters distance	assessed as seconds	90 days
Secondary	cerebral MRI	number of rim lesions; subgroup analysis	90 days
Secondary	36-Item Short Form Health Survey (SF-36)	Quality of Life, Questionnaire	90 days
Secondary	Magnetoencephalography (MEG)	Assessing neuronal slowing proposed as a marker of cognitive impairment in MS; Subgroup analysis	90 days
Secondary	9-hole peg test	assessed in seconds	90 days