Status:
ACTIVE_NOT_RECRUITING
Esketamine for the Treatment of Rett Syndrome
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Rett Syndrome
Eligibility:
FEMALE
5-10 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this interventional study is to learn about the efficacy and safety of Esketamine for treating children with Rett syndrome (RTT). The main questions it aims to answer are: * whether Eske...
Eligibility Criteria
Inclusion
- Classic/typical RTT
- Causing mutation in MECP2 gene
- Stable pattern of seizures, or has had no seizures at least 8 weeks
Exclusion
- Use of other drugs that interact with Esketamine: thyroxine, meglumine diatrizoate, aminophylline, diazepam or midazolam, drugs for antihypertension or central nervous depressants, halogenated general anesthetics (e.g., halothane), tubocurarine, atracurium
- Condition with hypertension, high cerebrospinal fluid pressure, and high intraocular pressure
- Unstable systemic illness other than Rett syndrome: current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes, or uncontrolled type 2 diabetes), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease), or major surgery planned during the study
- Clinically important variations in medication use
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06199700
Start Date
November 15 2023
End Date
May 1 2025
Last Update
February 18 2025
Active Locations (1)
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1
Xiamen Children's Hospital (Children's Hospital of Fudan University at Xiamen)
Xiamen, Fujian, China, 361006