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Clinical Trials in China / NCT06091332
Recruiting Phase 2

Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial

NCT06091332 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Phase 2
Started
2024-01-05
Last updated
2024-12-20

Condition(s) studied

Cavernous MalformationsIntracerebral HemorrhageBrainstem Stroke

Investigational drug(s) / intervention(s)

Sirolimus →Starch flake

Sirolimus: Sirolimus is an mTORC1 inhibitor that has received approval from the U.S. Food and Drug Administration (FDA) and has recently been successfully used to treat lymphatic malformations and venous/lymphatic malformations associated with the same PIK3CA GOF mutations.

Starch flake: The placebo is composed of starch material and is formulated at 0.5 grams per tablet.

Study summary

The aim of this pilot phase trial is to assess the safety and tolerability, and estimate the efficacy of sirolimus in reducing the incidence of ICH during high-risk periods for rebleeding, compared to placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-65 years, any gender; 2. Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation; 3. Diagnosed with solitary BSCM through T2, GRE/T2\*, or SWI MR imaging; 4. ICH within or around the BSCM confirmed by CT /MR; 5. Capable of signing an informed consent form with the accompaniment and understanding of a guardian. Exclusion Criteria: 1. Cancer history; 2. Pregnancy or lactation; 3. Sirolimus/starch allergy; 4. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment; 5. Abnormal liver and/or kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell/platelet counts (white blood cell count below 3.5 or above 9.5 x 109/L or exceeding normal values, platelet count below 100 or above 300); 6. History of previous immunosuppressive therapy; 7. History of prior surgical intervention for CCM ; 8. History of prior cranial radiation therapy ; 9. Familial CCM or people with multiple CCM; 10. Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections); 11. Uncontrolled diabetes mellitus; 12. Currently participating in another clinical trial; 13. Patient unwilling/unable to undergo MRI. 14. Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).

Primary outcome measure(s)

  • The primary outcome is to explore the safety of sirolimus in the management of BSCMs. — 24 months
    A serious adverse event is an SAE occurring during any study phase that fullfils one or more of the following criteria: i. Results in death, ii. Is life-threatening, iii. Requires inpatient hospitalization or prolongation of existing hospitalization, iv. Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, v. Is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above. SAE will be assessed at each follow-up visit (15 days, 2 months, 6 months, 12 months, 18 months, 24 months). During the trial, participants can promptly report potential SAEs to the research team via the telephone. We will establish continuous, real-time communication with patients via the telephone, facilitating round-the-clock reporting of potential endpoints or adverse reactions to the clinical trial investigators.

Trial sites (2)

FacilityCityRegionStatus
Huashan Hospital, Fudan University Shanghai Shanghai Municipality Active Not Recruiting
Huashan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation Starting soon
Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage Recruiting
RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH Recruiting
Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage Recruiting
Targeted Temperature Management Via Bladder Monitoring in ICH Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06091332 on ClinicalTrials.gov ↗ ← All trials in China