The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage
NCT Number: NCT06563817
Acronym: Saturn
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Communicating Hydrocephalus|Cerebral Intraventricular Hemorrhage|Secondary Normal Pressure Hydrocephalus|Post Hemorrhagic Hydrocephalus
Interventions: DRUG: Rapamycin
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 53
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-07
Locations: Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, 100070, China

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.

Primary Outcome Measures: The objective remission rate of rapamycin for 4 weeks in the treatment of communicating hydrocephalus secondary to intraventricular hemorrhage is evaluated using the Idiopathic Normal Pressure Hydrocephalus Grading Scale (IPNHGS)., Disease relief: Improvement of \>1 point on the Idiopathic Normal Pressure Hydrocephalus Grading Scale (iPNHGS) in patients after four weeks of rapamycin treatment compared to pre-treatment.

Objective remission rate: The ratio of the number of patients who have achieved disease remission to the total number of patients enrolled in the study., From the commencement of treatment to 4 weeks
Secondary Outcome Measures: Assessment of the incidence and severity of adverse events, serious adverse events, and other safety parameters (e.g., abnormal laboratory results) based on CTCAE V5.0, All events are determined based on CTCAE V5.0, From the commencement of treatment to 12 weeks after discontinuation of dosing|The objective remission rate of rapamycin treatment of communicating hydrocephalus secondary to intraventricular hemorrhage is evaluated using the Idiopathic Normal Pressure Hydrocephalus Grading Scale (IPNHGS)., Disease relief: Improvement of \>1 point on the Idiopathic Normal Pressure Hydrocephalus Grading Scale (iPNHGS) in patients after four weeks of rapamycin treatment compared to pre-treatment.

Objective remission rate: The ratio of the number of patients who have achieved disease remission to the total number of patients enrolled in the study., From the commencement of treatment to 2 weeks of dosing and 12 weeks after discontinuation of dosing|The objective remission rates of 3 clinical domains is evaluated using the Idiopathic Normal Pressure Hydrocephalus Grading Scale (IPNHGS)., The 3 clinical domains include: gait, urinary incontinence, and cognition. For gait, positive outcome was defined that improvement of \>1 point in the gait section of iNPHGS; for urinary incontinence, a positive outcome was defined that improvement of \>1 point in the urinary section of iNPHGS; For cognition, positive outcome was defined that improvement of \>1 point in the cognition section of iNPHGS, From the commencement to 2 weeks of dosing, 4 weeks of dosing and 12 weeks after discontinuation of dosing|Changes in plasma biomarkers, Change in plasma levels of TNF-α, IL-1β, IL-6, IL-10, IL-8 and IL-2R., From the commencement to 2 weeks of dosing, 4 weeks of dosing and 12 weeks after discontinuation of dosing|Change in CSF biomarkers, Change in plasma levels of TNF-α, IL-1β, IL-6, IL-10, IL-8 and IL-2R., From the commencement to 2 weeks of dosing, 4 weeks of dosing and 12 weeks after discontinuation of dosing|Change in Euro-Quality of Life-5 dimension-5L (EQ-5D-5L) descriptive system, Measured using EQ-5D-5L using the descriptive system., From the commencement to 2 weeks of dosing, 4 weeks of dosing and 12 weeks after discontinuation of dosing
Other Outcome Measures: Screening of potential beneficiary population, Identification of a patient population with secondary communicating hydrocephalus after intraventricular hemorrhage that may benefit from rapamycin therapy., From the commencement of treatment to 4 weeks