Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT06615206
Eligibility Criteria:
Inclusion Criteria:
* Males ≥ 2 and ≤18 years at the time of signing informed consent;
* Genetic test and clinical confirmed diagnosis of MDS;
* Stable pattern of seizures, or has had no seizures while currently receiving medical treatment (including antiepileptics) and physical therapy are stable for at least 2 months before screening;
* Willing to adhere to protocol, including biological samples collection and hospitalization for intracerebroventricular injection surgery;
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.
Exclusion Criteria:
* MECP2 gene triplication;
* Concurrent genetic syndromes other than MDS;
* Significant brain or cerebellar atrophy, or other significant degenerative changes as shown in cranial MRI at screening;
* Prior or current hypertension, cardiomyopathy, myocardial ischemia or atrial fibrillation and other cardiovascular diseases;
* Prior central nervous system surgery within 6 months before enrolment;
* Systemic use of immunosuppressive drugs within 3 months before enrolment;
* Prior gene therapy or oligonucleotide therapy treatments;
* Any other conditions that would not allow the potential subject to complete follow-up examinations during the study and would, in the opinion of the investigator, make the potential subject unsuitable for the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT06615206
Study Brief:
Protocol Section:
NCT06615206