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Could a 'Hibernation Cocktail' protect the brain after a stroke?

NCT ID NCT07364344

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 57 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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