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

Study acronym: CALM
StatusRecruiting
PhasePhase 2
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 60 to 75
    • Study sites: 1 to 2
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date changed from estimate of Dec 1, 2023 to Jan 5, 2024
    • Secondary endpoints: 3 to 4
    • Study title revised
    • Eligibility criteria expanded, about 1 word
  2. Primary endpoint revised
    • Interventions: Sirolimus (Drug) to Sirolimus (Drug), Starch flake (Drug)
    • Secondary endpoints: 2 to 3
    • Study title expanded, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Huashan Hospital
96 trials monitored
See 4 trials at risk
Stroke
3,531 trials monitored
See 153 trials at risk
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.
Trial Details
NCT Number NCT06091332
Lead Sponsor Huashan Hospital
Conditions
(from sponsor)		 Cavernous Malformations, Intracerebral Hemorrhage, Brainstem Stroke
Related terms Brain Stem Infarctions, Cerebral Hemorrhage
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov