Multiple Sclerosis (MS) Relapsing RemittingPhase 2NCT07263607
A Multicenter Clinical Trial Evaluating the Efficacy and Safety of Taurine as an Adjunctive Therapy in Multiple Sclerosis
A Phase 2 study testing DMTs + taurine and DMTs in people with Multiple Sclerosis (MS) Relapsing Remitting, run by Sichuan Academy of Medical Sciences.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS) Relapsing Remitting
- What is being tested?
- DMTs + taurine and DMTs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Clinical Study on Taurine Treatment for Multiple Sclerosis
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.
- Being tested
- DMTs + taurine, DMTs
- Keywords
- multiple sclerosis, taurine, multicenter, randomized, open-label clinical trial
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMTs + taurineDrug
DMTs + Taurine
DMTsDrug
DMTs
| Study group | Role | What they receive |
|---|---|---|
| Taurine + DMTs | Experimental | Experimental group Receives: Drug: DMTs + taurine |
| DMTs | Placebo comparator | control Receives: Drug: DMTs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (4)
EDSS score
Change in Expanded Disability Status Scale (EDSS) score to assess disability progression or improvement
Measured: From enrollment to the end of treatment at 2 years
Annualized Relapse Rate (ARR)
Number of confirmed clinical relapses per patient-year during the 24-month treatment period
Measured: From enrollment to the end of treatment at 2 years
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
Measured: From enrollment to the end of treatment at 2 years
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.
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS) Relapsing RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Tang-Du Hospital, The First Affiliated Hospital of Hainan Medical University, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263607
- Sponsor's protocol ID
- 2025-590-1
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33686135
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on Taurine Treatment for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07263607
- Acronym / sponsor ID
- 2025-590-1
- Keywords
- multiple sclerosis, taurine, multicenter, randomized, open-label clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Tang-Du Hospital, The First Affiliated Hospital of Hainan Medical University, 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
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurine + DMTs | Experimental | Drug: DMTs + taurineExperimental group |
| DMTs | Placebo comparator | Drug: DMTscontrol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMTs + taurineDMTs + Taurine | Drug | Taurine + DMTs |
| DMTsDMTs | Drug | DMTs |
Primary outcome
MRI leision activity
Time frame: 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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 33686135Tian 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DMTs + taurine and DMTs in people with Multiple Sclerosis (MS) Relapsing Remitting, run by Sichuan Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cunjin Zhang, MD, PhD (86-13645196561, zhangcunjin516@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI leision activity (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07263607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.