| NCT ID | NCT06241521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2034-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2024-02-01 with a primary completion date of 2034-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Myasthenia gravis (MG) is an autoimmune disease caused by dysfunction at the neuromuscular junction, characterized by partial or generalized skeletal muscle weakness and fatigability. The estimated annual incidence rate of MG in China is 0.68/100,000, with a high rate of relapse and poor treatment compliance. This study is a prospective, observational, multi-center patient registry across China. To support standardized management and follow-up of MG patients in China, a Cloud-based MG Patient Management Platform (CN MG Base) was established in September 2023 with the support of the Chinese Rare Diseases Alliance. The platform aims to collect longitudinal clinical data including demographic information, age of onset, medical history, comorbidities, medication usage, treatment responses, and others. It is intended to collect newly registered MG cases each year and follow up with these patients at one-year intervals for ten years
Eligibility Criteria
Inclusion Criteria: * Fluctuating weakness in skeletal muscles, such as extraocular, bulbar, limb muscles, etc.. Demonstrating fluctuation and fatigability: Weakness is usually worse in the morning and improves with rest; worsens with sustained activity. * Patients themselves or their guardians can understand and sign the informed consent form. To meet the eligibility criteria, at least one of the following additional criteria must be met: * a. Positive Tensilon test; * b. Decrease in compound muscle action potential by more than 10% with low-frequency repetitive nerve stimulation or widening of the "jitter" (the variability in time of the second action potential relative to the first) on single-fiber electromyography, with or without blocking; * c. Positive antibodies: Serum testing positive for AChR antibodies, MuSK antibodies, or LRP4 antibodies. Exclusion Criteria: * Patients with mental illness who cannot cooperate. * Patients with multiple organ dysfunction or in extremely critical condition, unable to complete relevant medical history collection or evaluation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06241521 clinical trial?
This trial is open to participants of all sexes, studying Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06241521 currently recruiting?
Yes, NCT06241521 is actively recruiting participants. Contact the research team at luosushan@fudan.edu.cn for enrollment information.
Where is the NCT06241521 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT06241521 clinical trial?
NCT06241521 is sponsored by Huashan Hospital. The trial plans to enroll 1,500 participants.