The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intravent
This prospective, multicenter, open-label clinical trial is designed to evaluate the safety and efficacy of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage. Additionally, the underlying pathogenic mechanisms associated with this particular type of hydrocephalus will be
| Condition(s) | Communicating Hydrocephalus, Cerebral Intraventricular Hemorrhage, Secondary Normal Pressure Hydrocephalus, Post Hemorrhagic Hydrocephalus |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This prospective, multicenter, open-label clinical trial is designed to evaluate the safety and efficacy of rapamycin in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage. Additionally, the underlying pathogenic mechanisms associated with this particular type of hydrocephalus will be investigated in greater depth, and populations that may benefit from rapamycin therapy will be identified. |
| Who can participate | Inclusion Criteria: 1. Patients with ventricular dilatation due to intraventricular hemorrhage who clinically present with any one or more of new gait disturbances, cognitive deficits, and urinary incontinence after remission of intraventricular hemorrhage symptoms, and whose brain imaging shows an Evans index (EI) of ≥0.3 2. Age ≥ 18 years and ≤ 70 years 3. Signed informed consent form Exclusion Criteria: 1. Participation in another medical trial 2. Have other disease that may affect the patient's symptoms (including gait disturbance, cognitive impairment, urinary incontinence) 3. Allergy to the investigational drug 4. Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values) 5. Reduced kidney function with GFR \< |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Beijing Tiantan Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-08 |
| NCT ID | NCT06563817 |
| Official listing | https://clinicaltrials.gov/study/NCT06563817 |