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

NCT07263607 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-590-1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis (MS) Relapsing Remitting

Keywords

multiple sclerosis; taurine; multicenter, randomized, open-label clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• EDSS score

  From enrollment to the end of treatment at 2 years

• Annualized Relapse Rate (ARR)

  From enrollment to the end of treatment at 2 years

• Gut Microbiota Composition

  From enrollment to the end of treatment at 2 years

• Serum Biomarkers (GFAP and NfL)

  From enrollment to the end of treatment at 2 years

Other Outcomes (1)

• Safety Outcome Measures

  From enrollment to the end of treatment at 2 years

Study Arms (2)

Taurine + DMTs

EXPERIMENTAL

Experimental group

Drug: DMTs + taurine

DMTs

PLACEBO COMPARATOR

control

Drug: DMTs

Interventions

DMTs + taurine DRUG

DMTs + Taurine

Taurine + DMTs

DMTs DRUG

DMTs

DMTs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 33686135 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Taurine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Cunjin Zhang, MD, PhD

CONTACT

86-13645196561; zhangcunjin516@163.com

Li Zeng, MD, PhD

CONTACT

86-17721863039; 346004863@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11