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

NCT ID: NCT07263607

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis (MS) Relapsing Remitting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Taurine + DMTs

Experimental group

Group Type EXPERIMENTAL

DMTs + taurine

Intervention Type DRUG

DMTs + Taurine

DMTs

control

Group Type PLACEBO_COMPARATOR

DMTs

Intervention Type DRUG

DMTs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DMTs + taurine

DMTs + Taurine

Intervention Type DRUG

DMTs

DMTs

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Hainan Medical College

UNKNOWN

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Daping Hospital of Army Medical University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

The People's Hospital of Leshan

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

Sichuan Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cunjin Zhang, MD, PhD

Role: CONTACT

86-13645196561

Li Zeng, MD, PhD

Role: CONTACT

86-17721863039

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33686135 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-590-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dose-finding Study of MT-1303
NCT01742052 COMPLETED PHASE2
Vitamin D3 and the Stress-axis in MS
NCT02096133 TERMINATED PHASE2