Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuashan Hospital
About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Cancer history;
Pregnancy or lactation;
Sirolimus/starch allergy;
Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;
Trial design
Treatments tested in this trial
- Sirolimus
- Starch flake
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov