Tests sirolimus to prevent brainstem bleeding from cavernous malformations
Tests sirolimus against placebo in adults with brainstem cavernous malformations at risk of bleeding.
Plain-language title generated from the registry record
Registry title: Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06091332, who can take part
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT06091332
- Record updated
- 20 December 2024
- Original description
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.Read full original descriptionShow less
Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: a Randomized, Placebo-controlled Pilot Trial
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.
Inclusion: Age 18-65 years, any gender; Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation; Diagnosed with solitary BSCM through T2, GRE/T2*, or SWI MR imaging; ICH within or around the BSCM confirmed by CT /MR; Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
Exclusion: History of previous immunosuppressive therapy; History of prior surgical intervention for CCM ; History of prior cranial radiation therapy ; Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections); Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin); Cancer history; Sirolimus/starch allergy; Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment; Uncontrolled diabetes mellitus; 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); Pregnancy or lactation; Familial CCM or people with multiple CCM; Currently participating in another clinical trial; Patient unwilling/unable to undergo MRI.