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

Phase 2Not Yet RecruitingNCT07263607

Sichuan Academy of Medical Sciences80 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis (MS) Relapsing Remitting

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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