Multiple Sclerosis (MS) Relapsing Remitting
Conditions
Keywords
multiple sclerosis, taurine, multicenter, randomized, open-label clinical trial
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.
Interventions
DRUGDMTs + taurine
DMTs + Taurine
DRUGDMTs
DMTs
Sponsors
First Affiliated Hospital of Chongqing Medical University
Tang-Du Hospital
The First Affiliated Hospital of Hainan Medical College
Lanzhou University Second Hospital
First Affiliated Hospital of Kunming Medical University
Daping Hospital of Army Medical University
Shandong Provincial Hospital
Affiliated Hospital of North Sichuan Medical College
Beijing Tiantan Hospital
The People's Hospital of Leshan
The Affiliated Hospital of Inner Mongolia Medical University
Sichuan Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI leision activity | From enrollment to the end of treatment at 2 years | Change in the number, size, and volume of new or enlarging T2 and Gd-enhancing T1 lesions on brain and spinal MRI scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EDSS score | From enrollment to the end of treatment at 2 years | Change in Expanded Disability Status Scale (EDSS) score to assess disability progression or improvement |
| Annualized Relapse Rate (ARR) | From enrollment to the end of treatment at 2 years | Number of confirmed clinical relapses per patient-year during the 24-month treatment period |
| Gut Microbiota Composition | From enrollment to the end of treatment at 2 years | 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 |
| Serum Biomarkers (GFAP and NfL) | From enrollment to the end of treatment at 2 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Measures | From enrollment to the end of treatment at 2 years | 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. |
Contacts
Primary ContactCunjin Zhang, MD, PhD
Backup ContactLi Zeng, MD, PhD
Outcome results
None listed