Could a 'Hibernation Cocktail' protect the brain after a stroke?
NCT ID NCT07364344
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether a combination of two drugs (chlorpromazine and promethazine) can safely put stroke patients into a hibernation-like state to protect the brain. The trial will enroll 57 adults with acute ischemic stroke who are eligible for clot-removal therapy. Researchers will first find the safest dose, then check if it reduces brain damage and improves symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Chlorpromazine and Promethazine (drug combination)
- What this could lead to
- If safe and effective, this approach could reduce brain damage and improve recovery after a stroke.
- What could go wrong
- This is a very early, small Phase I safety study with only 57 people. The drugs may not work as hoped or could cause serious side effects like low blood pressure or sedation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 57 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Male or female, aged 18 to 80 years (inclusive). 3. Diagnosis of acute ischemic stroke eligible for endovascular therapy. 4. 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). Note: The NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficits. Classification: * \*0-1: Normal or near-normal.\* * \*1-4: Minor stroke.\* * \*5-15: Moderate stroke.\* * \*15-20: Moderate to severe stroke.\* * \*21-42: Severe stroke.\* 5. Time from stroke onset to planned drug administration is within 24 hours. 6. Pre-stroke modified Rankin Scale (mRS) score of 0 or 1. 7. Expected survival greater than 90 days. 8. Imaging Inclusion Criteria: * Pre-procedural angiographic evaluation (NCCT + CTA + CTP / DSA) confirms a large vessel occlusion (internal carotid artery or M1 segment of middle cerebral artery) consistent with clinical symptoms. * Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. * Perfusion-core mismatch: Ischemic core volume 5-70 mL, with a mismatch ratio (volume of hypoperfused tissue / volume of ischemic core) ≥ 1.8 and a mismatch volume ≥ 15 mL. 9. Adequate organ function at screening, defined as: * Platelet count \> 100 × 10⁹/L. * Liver and renal function: ALT/AST ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN; Creatinine clearance (Ccr) \> 60 mL/min. 10. Female subjects of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion. A negative pregnancy test is required within 7 days prior to enrollment. All subjects (male or female) must employ adequate contraceptive measures throughout the treatment period and for 6 months thereafter. (A negative pregnancy test result is mandatory for women of childbearing potential before enrollment). Exclusion Criteria: 1. Presence of pathological fever at screening: axillary temperature ≥ 37.3°C or tympanic membrane temperature ≥ 37.9°C. 2. Clinical presentation suggestive of intracranial parenchymal hemorrhage or subarachnoid hemorrhage (even with normal imaging findings). 3. Stroke onset accompanied by seizures at screening, precluding accurate NIHSS assessment. 4. Coma or psychiatric disorders at screening that interfere with neurological evaluation. 5. 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. 6. History of severe infusion reactions deemed ineligible for inclusion upon evaluation. 7. History of allergy or anaphylactic shock to iodinated contrast agents. 8. Major surgery within 4 weeks prior to drug administration. 9. Blood glucose \<50 mg/dL (2.78 mmol/L) or \>400 mg/dL (22.20 mmol/L) prior to drug administration (fingerstick glucose results acceptable). 10. History of deep vein thrombosis within 6 months prior to drug administration. 11. Previous endovascular thrombectomy performed less than 3 months prior. 12. Clinically significant active bleeding (e.g., gastrointestinal or other) within 30 days prior to drug administration; coagulation factor abnormalities or bleeding tendency (e.g., on anticoagulants with INR ≥3 or PT ≥3×ULN). However, subjects may be enrolled without awaiting coagulation results if the investigator deems no coagulation dysfunction. Active infection requiring systemic therapy within 2 weeks prior to drug administration (e.g., active tuberculosis). 13. Clinically significant cardiac disease at screening, including but not limited to: * Uncontrolled hypertension (SBP \>180 mmHg or DBP \>105 mmHg after standard treatment) or hypotension (SBP ≤100 mmHg after standard treatment). * Unstable angina, myocardial infarction, or coronary artery bypass graft/stent placement within 6 months prior to drug administration. * History of chronic heart failure (NYHA Class 3-4), or valvular heart disease, deemed ineligible by the investigator. 14. Severe arrhythmia requiring treatment or presence of QT interval prolongation at screening, deemed ineligible by the investigator. 15. Severe systemic disease at screening deemed ineligible by the investigator, including but not limited to: pulmonary embolism, pulmonary hypertension, severe COPD, active tuberculosis, severe pneumonia, pneumothorax, severe atelectasis, severe pulmonary fibrosis, bronchopulmonary dysplasia, unstable pleural effusion, acute respiratory distress syndrome, irregular breathing patterns or other severe pulmonary diseases; severe hepatic or renal insufficiency such as cirrhosis, hepatic encephalopathy, ascites, obstructive jaundice, renal failure, or uremia. 16. Pregnant or lactating women. 17. Participation in an interventional clinical trial involving investigational drugs or medical devices within 28 days prior to screening. 18. Subjects considered inappropriate for inclusion by the investigator. Imaging Exclusion Criteria: 1. CTA+CTP/DSA demonstrates excessive vascular tortuosity that may impede delivery of interventional devices. 2. Suspected cerebral vasculitis based on history and NCCT+CTA+CTP/DSA findings. 3. Suspected aortic dissection based on history and NCCT+CTA+CTP/DSA findings. 4. NCCT+CTA+CTP/DSA confirms occlusion in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation, extracranial carotid with intracranial tandem lesions), or clinical evidence of bilateral or multifocal infarction. 5. NCCT+CTA+CTP/DSA confirms moyamoya disease or moyamoya syndrome. 6. NCCT+CTP confirms significant mass effect with midline shift. 7. NCCT (or MRI) confirms presence of an intracranial tumor (except small meningiomas). 8. NCCT confirms presence of intracranial hemorrhage. 9. CTA misdiagnosis of large vessel occlusion (internal carotid artery or MCA M1 segment) where DSA angiography reveals no culprit vessel occlusion. 10. CTA misdiagnosis of a single anterior circulation large vessel occlusion where DSA angiography reveals occlusion of multiple major arterial trunks.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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