Clinical Trial

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

Study acronym: CALM
Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated December 20, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-13; most recent amendment 2024-12-17.
Status change: Not Yet Recruiting → Recruiting 2024-12-17
Trial Details
NCT Number NCT06091332
Lead Sponsor Huashan Hospital
Conditions Cavernous Malformations, Intracerebral Hemorrhage, Brainstem Stroke
Enrollment 75 participants
Start Date 2024-01-05
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-20