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Not yet recruiting NCT07263607

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

Phase II Interventional Multiple Sclerosis (MS) Relapsing Remitting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DMTs + taurine, DMTs.
Who it may be relevant to
Registry conditions: Multiple Sclerosis (MS) Relapsing Remitting. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Clinical Study on Taurine Treatment for Multiple Sclerosis

Overview

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.

Interventions

  • Drug DMTs + taurine
    DMTs + Taurine
  • Drug DMTs
    DMTs

Primary outcome measures

  • MRI leision activity [Time frame: From enrollment to the end of treatment at 2 years]
Secondary outcome measures (4)
  • EDSS score [Time frame: From enrollment to the end of treatment at 2 years]
  • Annualized Relapse Rate (ARR) [Time frame: From enrollment to the end of treatment at 2 years]
  • Gut Microbiota Composition [Time frame: From enrollment to the end of treatment at 2 years]
  • Serum Biomarkers (GFAP and NfL) [Time frame: From enrollment to the end of treatment at 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 33686135

Identifiers

NCT: NCT07263607 · 2025-590-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗