Evaluating rapamycin for treating communicating hydrocephalus after brain 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

This study is testing if rapamycin can help people with communicating hydrocephalus caused by brain bleeding feel better and improve their symptoms over four weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06563817 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, open-label clinical trial aims to assess the safety and efficacy of rapamycin in patients suffering from communicating hydrocephalus secondary to intraventricular hemorrhage. The study will involve administering rapamycin over a four-week period to evaluate its impact on symptoms such as gait disturbances, cognitive deficits, and urinary incontinence. Additionally, the trial will investigate the underlying mechanisms contributing to this condition and identify patient populations that may benefit from rapamycin therapy. The study's design includes monitoring for efficacy and adverse effects throughout the treatment course.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with ventricular dilatation due to intraventricular hemorrhage and associated symptoms.

Not a fit: Patients with other diseases affecting their symptoms, severe liver or kidney dysfunction, or those currently participating in other medical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from debilitating symptoms of communicating hydrocephalus, potentially improving their quality of life.

How similar studies have performed: While this approach is novel in the context of treating communicating hydrocephalus, previous studies have shown promise in targeting the PI3K-AKT-mTOR pathway with rapamycin in related conditions.

Eligibility criteria

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 \< 50
6. Concomitant treatment with strong CYP3A4/5 inducers or inhibitors, such as diltiazem, ketoconazole, or rifampicin.
7. Active or uncontrolled chronic infection
8. Women who are pregnant or breastfeeding
9. Patients who are bedridden or require urinary catheters for extended periods of time.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Runfa Tian, MD

Conditions Communicating Hydrocephalus; Cerebral Intraventricular Hemorrhage; Secondary Normal Pressure Hydrocephalus; Post Hemorrhagic Hydrocephalus; Rapamycin