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

ConditionMultiple Sclerosis (MS) Relapsing Remitting
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSichuan Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DMTs + taurine

    Drug

    DMTs + Taurine

  • DMTs

    Drug

    DMTs

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Taurine + DMTsExperimental treatment 1 intervention
Group B: DMTsPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
From enrollment to the end of treatment at 2 years

Secondary outcomes

1

EDSS score

Change in Expanded Disability Status Scale (EDSS) score to assess disability progression or improvement

Time frame
From enrollment to the end of treatment at 2 years
2

Annualized Relapse Rate (ARR)

Number of confirmed clinical relapses per patient-year during the 24-month treatment period

Time frame
From enrollment to the end of treatment at 2 years
3

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

Time frame
From enrollment to the end of treatment at 2 years
4

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.

Time frame
From enrollment to the end of treatment at 2 years

Other outcomes

1

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.

Time frame
From enrollment to the end of treatment at 2 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Academy of Medical Sciences

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Collaborator

Tang-Du Hospital

Collaborator

The First Affiliated Hospital of Hainan Medical University

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: