A Multicenter Clinical Trial Evaluating the Efficacy and Safety of Taurine as an Adjunctive Therapy in Multiple Sclerosis

A Multicenter Clinical Study on Taurine Treatment for Multiple Sclerosis

This multicenter, randomized, open-label clinical trial aims to evaluate the efficacy and safety of taurine as an adjunctive therapy to standard disease-modifying treatments (DMTs) in patients with multiple sclerosis (MS). The study seeks to determine whether oral taurine can reduce the number and volume of new or enlarging MRI lesions, decrease relapse rates, and slow disability progression as measured by the Expanded Disability Status Scale (EDSS). It will also explore the effects of taurine on gut microbiota composition, serum neurodegeneration biomarkers (GFAP and NfL), and cognitive function assessed by MMSE and MoCA. Approximately 80 eligible participants will be enrolled and randomly assigned to either continue standard DMT therapy or receive taurine supplementation in addition to DMTs. The treatment duration will be 24 months, with follow-up visits every 3 months for clinical assessment, blood and stool sample collection, and MRI scans every 6 months. This study aims to provide new clinical evidence supporting taurine as a safe and potentially beneficial adjunctive therapy for multiple sclerosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis (MS) Relapsing Remitting
• Intervention / Treatment: Drug: DMTs + taurine; Drug: DMTs

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cunjin Zhang, MD, PhD; Phone Number: 86-13645196561; Email: zhangcunjin516@163.com
• Study Contact Backup: Name: Li Zeng, MD, PhD; Phone Number: 86-17721863039; Email: 346004863@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.Age and Gender: Male or female participants aged 18 to 65 years.
• 2.Diagnosis: Patients diagnosed with multiple sclerosis (MS) according to the 2017 revised McDonald criteria.
• 3.Treatment Background: Patients receiving stable disease-modifying therapy (DMT) prior to enrollment.
• 4. EDSS score between 1.0 and 5.5 at screening.
• 5. Compliance: Ability and willingness to comply with all study procedures, follow-up visits, and study medication requirements.
• 6.Informed Consent: Participants must provide written informed consent before any study-specific procedures are performed.
• 7 Female participants must be non-pregnant and non-lactating, or, if of childbearing potential, must agree to use effective contraception during the study

Exclusion Criteria:

• 1. Patients with known hypersensitivity to taurine or any of its components
• 2. Women who are pregnant or breastfeeding
• 3. Patients currently participating in other clinical trials
• 4. Patients who refuse to participate in the relevant clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taurine + DMTs; Experimental group	Drug: DMTs + taurine; DMTs + Taurine
Placebo Comparator: DMTs; control	Drug: DMTs; DMTs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI leision activity	Change in the number, size, and volume of new or enlarging T2 and Gd-enhancing T1 lesions on brain and spinal MRI scans	From enrollment to the end of treatment at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EDSS score	Change in Expanded Disability Status Scale (EDSS) score to assess disability progression or improvement	From enrollment to the end of treatment at 2 years
Annualized Relapse Rate (ARR)	Number of confirmed clinical relapses per patient-year during the 24-month treatment period	From enrollment to the end of treatment at 2 years
Gut Microbiota Composition	Alterations in gut microbial diversity and relative abundance of key taxa analyzed by 16S rRNA sequencing of stool samples at baseline, Month 12, and Month 24	From enrollment to the end of treatment at 2 years
Serum Biomarkers (GFAP and NfL)	Change in serum levels of glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) from baseline to Month 24 as indicators of neuroinflammation and axonal injury.	From enrollment to the end of treatment at 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome Measures	All adverse events occurring during the study period will be recorded, including their onset time, duration, severity, outcome, and relationship to the study drug (taurine). Serious adverse events will be reported immediately according to GCP requirements.	From enrollment to the end of treatment at 2 years

Collaborators and Investigators

• Sponsor: Sichuan Academy of Medical Sciences
• Collaborators: Beijing Tiantan Hospital; Shandong Provincial Hospital; Tang-Du Hospital; First Affiliated Hospital of Chongqing Medical University; The Affiliated Hospital of Inner Mongolia Medical University; The People's Hospital of Leshan; Affiliated Hospital of North Sichuan Medical College; Lanzhou University Second Hospital; Daping Hospital of Army Medical University; First Affiliated Hospital of Kunming Medical University; The First Affiliated Hospital of Hainan Medical College

Publications and helpful links

General Publications

• Tian J, Song M, Kaufman DL. Homotaurine limits the spreading of T cell autoreactivity within the CNS and ameliorates disease in a model of multiple sclerosis. Sci Rep. 2021 Mar 8;11(1):5402. doi: 10.1038/s41598-021-84751-3.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: multiple sclerosis; taurine; multicenter, randomized, open-label clinical trial
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sulfur Compounds; Organic Chemicals; Hydrocarbons, Acyclic; Hydrocarbons; Alkanes; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Taurine
• Other Study ID Numbers: 2025-590-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No