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RecruitingPhase 2NCT06563817

The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage

A Prospective, Multi-center, Open-label Study to Observe the Efficacy and Safety of Rapamycin in the Treatment of Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage

Sponsor

Beijing Tiantan Hospital

Enrollment

53 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Communicating HydrocephalusCerebral Intraventricular HemorrhageSecondary Normal Pressure HydrocephalusPost Hemorrhagic Hydrocephalus

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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
  • Age ≥ 18 years and ≤ 70 years
  • Signed informed consent form

Exclusion Criteria9

  • Participation in another medical trial
  • Have other disease that may affect the patient's symptoms (including gait disturbance, cognitive impairment, urinary incontinence)
  • Allergy to the investigational drug
  • Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values)
  • Reduced kidney function with GFR \< 50
  • Concomitant treatment with strong CYP3A4/5 inducers or inhibitors, such as diltiazem, ketoconazole, or rifampicin.
  • Active or uncontrolled chronic infection
  • Women who are pregnant or breastfeeding
  • Patients who are bedridden or require urinary catheters for extended periods of time.
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Interventions

DRUGRapamycin

All enrolled patients receive treatment with sirolimus (rapamycin)#The prescribed regimen involved a daily oral dosage of 1.5 mg for a duration of four weeks.

Locations(1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT06563817