Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in ā¦ (NCT07364344) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for Reperfusion Therapy.
57 participantsStarted 2026-01
Plain-language summary
This is a single-center, dose-escalation and dose-expansion Phase I study designed to evaluate the safety of hibernation-like therapy (Chlorpromazine and Promethazine, C+P) and observe improvements in infarct volume in patients with AIS eligible for reperfusion therapy.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. The subject or their legal guardian voluntarily agrees to participate by providing written informed consent, and agrees to comply with the trial treatment plan and visit schedule.
ā. Male or female, aged 18 to 80 years (inclusive).
ā. Diagnosis of acute ischemic stroke eligible for endovascular therapy.
ā. Clinical signs and symptoms consistent with acute anterior circulation ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20 (inclusive).
ā. Time from stroke onset to planned drug administration is within 24 hours.
ā. Pre-stroke modified Rankin Scale (mRS) score of 0 or 1.
ā. Expected survival greater than 90 days.
ā. Imaging Inclusion Criteria:
Exclusion criteria
ā. Presence of pathological fever at screening: axillary temperature ā„ 37.3Ā°C or tympanic membrane temperature ā„ 37.9Ā°C.
ā. Clinical presentation suggestive of intracranial parenchymal hemorrhage or subarachnoid hemorrhage (even with normal imaging findings).
ā. Stroke onset accompanied by seizures at screening, precluding accurate NIHSS assessment.
ā. Coma or psychiatric disorders at screening that interfere with neurological evaluation.
What they're measuring
1
Observation of DLT and MTD across different C+P dose cohorts to determine the RP2D.
Timeframe: From the initiation of Hibernation-Like Therapy until 7 days after treatment.
ā. Conditions contraindicating phenothiazine use at screening, such as Parkinson's disease, parkinsonism, basal ganglia disorders, bone marrow suppression, glaucoma, epilepsy, history of neuroleptic malignant syndrome, or history of hypersensitivity to phenothiazines.
ā. History of severe infusion reactions deemed ineligible for inclusion upon evaluation.
ā. History of allergy or anaphylactic shock to iodinated contrast agents.
ā. Major surgery within 4 weeks prior to drug administration.