RecruitingPhase 2

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

China75 participantsStarted 2024-01-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Cancer history;
✕. Pregnancy or lactation;
✕. Sirolimus/starch allergy;
✕. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
✕. 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);
✕. History of previous immunosuppressive therapy;
✕. History of prior surgical intervention for CCM ;
✕. History of prior cranial radiation therapy ;

What they're measuring

The primary outcome is to explore the safety of sirolimus in the management of BSCMs.

Timeframe: 24 months

Trial details

NCT IDNCT06091332

SponsorHuashan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Zongze Li, Doctor

+8613121226581 lizongze666@aliyun.com

View on ClinicalTrials.gov More Cavernous Malformations trials