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Tests treatment safety and results for Communicating Hydrocephalus
Official title The Safety and Efficacy of Rapamycin on Communicating Hydrocephalus Secondary to Intraventricular Hemorrhage
ClinicalTrials.gov ID: NCT06563817
What this study is testing
What is Rapamycin?
Rapamycin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for communicating hydrocephalus.
Also referred to as Sirolimus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with ventricular dilatation due to intraventricular hemorrhage who clinically present with any one or more of new gait disturbances...
- Age ≥ 18 years and ≤ 70 years
- Signed informed consent form
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- Age ≥ 18 years and ≤ 70 years
- Signed informed consent form
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.