Neuromyelitis Optica Spectrum Disorders (NMOSD)NCT06888622
BLAZE-Limiting Approach in NMOSD
An observational study of Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Huashan Hospital at 1 site in China.
Trial summary
This is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders (NMOSD)
- What is being tested?
- Eculizumab administration
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 3 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational cohort study based on data from the prospectively followed NMOSD cohort of the hospital-based registry (The Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab were enrolled.
Who may be able to join
- (1)Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody; (2) Age ≥ 18 years; (3) Received eculizumab during an acute phase of NMOSD, defined as within 30 days of attack onset； (4) Adherence to an 8-week follow-up from eculizumab initiation.
Who cannot join
- Patients with unresolved Neisseria meningitidis infection or severe infections that preclude the use of immunotherapy;
- Patients with severe comorbidities (such as heart failure, respiratory failure, severe hepatic or renal dysfunction, etc.);
- Patients with incomplete records of clinical symptoms and signs, as well as insufficient data on serum marker tests in their medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eculizumab for Blaze-limiting Approach in NMOSD: A Prospective Study
This is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab, and 9 of them were included in this study.
- Being tested
- Eculizumab administration
- Keywords
- NMOSD, eculizumab, AQP4-ab, Neuromyelitis Optica Spectrum Disorders
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eculizumab administrationDrug
Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab treatment group | Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks Receives: Drug: Eculizumab administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in disability status measured by the MRC scale score
Measured by the MRC scale score for patients with LETM
Measured: 0, 1, 2, 3, 4, 8 weeks
The change in disability status
Measured by the best corrected visual acuity (BCVA)
Measured: 0, 1, 2, 3, 4, 8 weeks
Secondary outcomes (4)
Incidence of AEs and SAEs during eculizumab treatment
dverse events were coded using MedDRA version 27.1. Adverse events were analyzed in the safety analysis population (all patients who received at least one dose of study treatment) in terms of percentage incidence and as rates by exposure time (number of events per 100 patient-years of exposure and the associated 95% CI) to adjust for any differences in duration of exposure. The severity of adverse events was measured by NCI CTCAE version 5.0.
Measured: 1, 2, 3, 4, 8 weeks
The Change in Expanded Disability Status Scale (EDSS) scores
Measured by Expanded Disability Status Scale (EDSS) scores for the entire cohort.
Measured: 0, 1, 2, 3, 4, 8 weeks
The Change in Opticospinal Impairment Scale (OSIS) scores
Measured by Opticospinal Impairment Scale (OSIS) for the entire cohort.
Measured: 0, 1, 2, 3, 4, 8 weeks
The change in Visual Functional System Score (VFSS)
Measured by Visual Functional System Score (VFSS) for patients with ON.
Measured: 0, 1, 2, 3, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Oct 2023
- Primary completion1 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorders (NMOSD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Quan, Huashan Hospital
- Investigators
- Chao Quan, Doctor, Principal investigator, Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888622
- Sponsor's protocol ID
- KY2025-062
- Other IDs
- MR-31-22-008563; ChiCTR2000030
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eculizumab for Blaze-limiting Approach in NMOSD: A Prospective Study
- ClinicalTrials.gov ID
- NCT06888622
- Acronym / sponsor ID
- KY2025-062
- Keywords
- NMOSD, eculizumab, AQP4-ab, Neuromyelitis Optica Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 21 Mar 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 is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab, and 9 of them were included in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eculizumab treatment group | – | Drug: Eculizumab administrationEculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational cohort study based on data from the prospectively followed NMOSD cohort of the hospital-based registry (The Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab were enrolled.
Key inclusion criteria (1 listed)
- (1)Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody; (2) Age ≥ 18 years; (3) Received eculizumab during an acute phase of NMOSD, defined as within 30 days of attack onset； (4) Adherence to an 8-week follow-up from eculizumab initiation.
Key exclusion criteria (3 listed)
- Patients with unresolved Neisseria meningitidis infection or severe infections that preclude the use of immunotherapy;
- Patients with severe comorbidities (such as heart failure, respiratory failure, severe hepatic or renal dysfunction, etc.);
- Patients with incomplete records of clinical symptoms and signs, as well as insufficient data on serum marker tests in their medical records.
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 |
|---|---|---|
| Eculizumab administrationEculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks | Drug | Eculizumab treatment group |
Primary outcome
The change in disability status measured by the MRC scale score
Time frame: 0, 1, 2, 3, 4, 8 weeks
Measured by the MRC scale score for patients with LETM
The change in disability status
Time frame: 0, 1, 2, 3, 4, 8 weeks
Measured by the best corrected visual acuity (BCVA)
4 secondary outcomes
Incidence of AEs and SAEs during eculizumab treatment
Time frame: 1, 2, 3, 4, 8 weeks
The Change in Expanded Disability Status Scale (EDSS) scores
Time frame: 0, 1, 2, 3, 4, 8 weeks
The Change in Opticospinal Impairment Scale (OSIS) scores
Time frame: 0, 1, 2, 3, 4, 8 weeks
The change in Visual Functional System Score (VFSS)
Time frame: 0, 1, 2, 3, 4, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- 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. This study is not recruiting at the moment.
Chao Quan, Doctor principal investigator
Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
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 Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Huashan Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 21 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in disability status measured by the MRC scale score (time frame: 0, 1, 2, 3, 4, 8 weeks). 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 21 Mar 2025.