Multiple Sclerosis, MSNCT06541626
Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases
An observational study of Multiple Sclerosis, MS and Neuromyelitis Optica Spectrum Disorders, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, MS, Neuromyelitis Optica Spectrum Disorders, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2035
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases
Who may be able to join
- Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
- The clinical syndrome of the attack meets one of the following: MS, NMOSD, MOGAD, ADEM, clinically isolated syndrome, demyelinating encephalopathy, demyelinating myelitis, or brainstem encephalitis (see below A-E);
- Agree to participate in this study and sign the informed consent form.
Who cannot join
- History of tumors or diagnosis of central nervous system tumors;
- Infectious lesions of the central nervous system;
- Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord;
- Non-compliance with treatment and follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Hongxuan Wang, 86-13824498978, wanghx8@mail.sysu.edu.cn
About this study
Official title: Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases
The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.
The main questions it aims to answer are:
Read more
Question 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.
Question 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.
Participants will
- Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions.
- Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.
- Conditions
- Multiple Sclerosis, MS, Neuromyelitis Optica Spectrum Disorders, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Acute Disseminated Encephalomyelitis, Clinically Isolated Syndrome, Demyelinating Disorder
- Keywords
- CNS IIDD, follow-up
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Encephalomyelitis, Acute Disseminated, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS | Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | |
| NMOSD | Diagnosis meets the 2015 IPND diagnostic panel standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | |
| MOGAD | Diagnosis meets the 2023 international expert panel recommended standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | |
| ADEM | Diagnosis meets the diagnostic criteria for ADEM | |
| CIS | Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | |
| undefined CNS IIDD | First occurrence of CNS inflammatory demyelinating event, not yet diagnosable as MS, NMOSD, MOGAD, ADEM, or other definitive types of central nervous system demyelinating diseases, with symptoms and signs lasting more than 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Must meet the following criteria：① Appearance of new symptoms or worsening of existing symptoms;② Symptoms attributed to CNS IIDD;③ Duration ≥24 hours;④ Increase in clinical scores (e.g., EDSS);⑤ Imaging or electrophysiological tests clearly showing new responsible lesions.
Measured: Through study completion, an average of 5 years
Long-term neurological function
Assessed using the Expanded Disability Status Scale (EDSS)，EDSS score ranges from 0 to 10, with 0 indicating a normal healthy state, 10 indicating death, and higher scores reflecting more severe disability.
Measured: Through study completion, an average of 5 years
Secondary outcomes (11)
Long-term neurological function
Assessed using the Optic Spinal Impairment Scale (OSIS) and its sub-scores, OSIS score ranges from 0 to 25, and higher scores reflect more severe disability. OSIS sub-score ranges from 0 to 5-8, and higher scores reflect more severe in each component assessment.
Measured: Baseline, six months, one year, two years, and average three years
Sub-scores of the Expanded Disability Status Scale (EDSS)
EDSS sub-score ranges from 0 to 5 or 6, with 0 indicating a normal healthy state, higher scores indicating worse neurological functions.
Measured: Baseline, six months, one year, two years, and average three years
Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness
The thickness is measured by machines by milimetres
Measured: Baseline, six months, one year, two years, and average three years
Changes in humoral immune markers
The levels of neurofilament light chain (NfL), soluble GFAP, soluble TREM2, and other potential biomarkers are measured in g/ml.
Measured: Baseline, six months, one year, two years, and average three years
Changes in pathogenic antibody titers
Titers of antibodies for MOG, AQP4, MBP, and AFO in iu/l
Measured: Baseline, six months, one year, two years, and average three years
P100 amplitude of visual evoked potentials
Amplitude in volts
Measured: Baseline, six months, one year, two years, and average three years
P100 latency of visual evoked potentials
Latency in seconds
Measured: Baseline, six months, one year, two years, and average three years
Latency of somatosensory evoked potentials;
Latency in seconds
Measured: Baseline, six months, one year, two years, and average three years
Latency of brainstem auditory evoked potentials;
Latency in seconds
Measured: Baseline, six months, one year, two years, and average three years
Amplitude of somatosensory evoked potentials;
Amplitude in volts
Measured: Baseline, six months, one year, two years, and average three years
Amplitude of brainstem auditory evoked potentials;
Amplitude in volts
Measured: Baseline, six months, one year, two years, and average three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, MSStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541626
- Sponsor's protocol ID
- SYSKY-2024-109-01
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases
- ClinicalTrials.gov ID
- NCT06541626
- Acronym / sponsor ID
- SYSKY-2024-109-01
- Conditions
- Multiple Sclerosis, MS, Neuromyelitis Optica Spectrum Disorders, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Acute Disseminated Encephalomyelitis, Clinically Isolated Syndrome, Demyelinating Disorder
- Keywords
- CNS IIDD, follow-up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 7 Aug 2024 (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.
The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.
The main questions it aims to answer are:
Question 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.
Question 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.
Participants will
- Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions.
- Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MS | – | –Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. |
| NMOSD | – | –Diagnosis meets the 2015 IPND diagnostic panel standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. |
| MOGAD | – | –Diagnosis meets the 2023 international expert panel recommended standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. |
| ADEM | – | –Diagnosis meets the diagnostic criteria for ADEM |
| CIS | – | –Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. |
| undefined CNS IIDD | – | –First occurrence of CNS inflammatory demyelinating event, not yet diagnosable as MS, NMOSD, MOGAD, ADEM, or other definitive types of central nervous system demyelinating diseases, with symptoms and signs lasting more than 24 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases
Key inclusion criteria (3 listed)
- Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
- The clinical syndrome of the attack meets one of the following: MS, NMOSD, MOGAD, ADEM, clinically isolated syndrome, demyelinating encephalopathy, demyelinating myelitis, or brainstem encephalitis (see below A-E);
- Agree to participate in this study and sign the informed consent form.
Key exclusion criteria (4 listed)
- History of tumors or diagnosis of central nervous system tumors;
- Infectious lesions of the central nervous system;
- Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord;
- Non-compliance with treatment and follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse
Time frame: Through study completion, an average of 5 years
Must meet the following criteria：① Appearance of new symptoms or worsening of existing symptoms;② Symptoms attributed to CNS IIDD;③ Duration ≥24 hours;④ Increase in clinical scores (e.g., EDSS);⑤ Imaging or electrophysiological tests clearly showing new responsible lesions.
Long-term neurological function
Time frame: Through study completion, an average of 5 years
Assessed using the Expanded Disability Status Scale (EDSS)，EDSS score ranges from 0 to 10, with 0 indicating a normal healthy state, 10 indicating death, and higher scores reflecting more severe disability.
11 secondary outcomes
Long-term neurological function
Time frame: Baseline, six months, one year, two years, and average three years
Sub-scores of the Expanded Disability Status Scale (EDSS)
Time frame: Baseline, six months, one year, two years, and average three years
Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness
Time frame: Baseline, six months, one year, two years, and average three years
Changes in humoral immune markers
Time frame: Baseline, six months, one year, two years, and average three years
Changes in pathogenic antibody titers
Time frame: Baseline, six months, one year, two years, and average three years
P100 amplitude of visual evoked potentials
Time frame: Baseline, six months, one year, two years, and average three years
P100 latency of visual evoked potentials
Time frame: Baseline, six months, one year, two years, and average three years
Latency of somatosensory evoked potentials;
Time frame: Baseline, six months, one year, two years, and average three years
Latency of brainstem auditory evoked potentials;
Time frame: Baseline, six months, one year, two years, and average three years
Amplitude of somatosensory evoked potentials;
Time frame: Baseline, six months, one year, two years, and average three years
Amplitude of brainstem auditory evoked potentials;
Time frame: Baseline, six months, one year, two years, and average three 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 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, MS and Neuromyelitis Optica Spectrum Disorders, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Hongxuan Wang (86+13824498978, wanghx8@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: Through study completion, an average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.