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New drug aims to shield brain cells during emergency stroke procedure

NCT ID NCT05585606

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called SCP776 in 120 adults having emergency surgery to remove a blood clot after a severe stroke. The goal was to see if the drug is safe and helps protect the brain from further damage. Participants received either the drug or a placebo, and researchers monitored side effects and recovery.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

Oct 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Aged 18 years or older. * Body weight of less than 150 kg. * AIS intended for immediate endovascular treatment. * Disabling stroke defined as a baseline NIHSS ≥6 at the time of randomization. * Confirmed symptomatic intracranial occlusion, based on qualifying imaging, at one or more of the following locations: intracranial carotid artery and/or M1 or M2 middle cerebral artery. * Onset of AIS (last time subject seen well) to randomization is ≤24 hours. * Intended endovascular treatment with an approved endovascular device. * Pre-AIS (24 hours before stroke onset) independent functional status in activities of daily living with Modified Rankin Scale score of 0, 1, or 2. Subject must be living in their own home, apartment, or seniors' lodge where no nursing care is required. * Treating team and subject family are committed to full medical support for the subject. * Signed informed consent from subject or legally authorized representative, if required to enable inclusion by applicable national laws and regulations and the applicable independent review boards/ethics committee requirements for obtaining consent. Electronic consent is allowed in jurisdictions wherein this consent process is allowed. * Biologically female subjects must meet the following: 1. Subject must be surgically sterile or be at least 1 year postmenopausal, OR 2. Subjects of child-bearing potential must: i. have a negative serum or urine pregnancy test at Screening, AND ii. have no plans to become pregnant or to breast feed during the study, AND iii. at least one of the following must apply: 1. have a monogamous partner who is surgically sterile. 2. have a monogamous same sex partner. 3. be practicing abstinence or using an acceptable form of birth control while participating in the study through Day 90. Site personnel will provide instructions on what is an acceptable method. * If male, unless the subject has a same sex partner, be either sterile (surgically or biologically), commit to an acceptable double barrier method of birth control, or practice abstinence, until at least 30 days after study drug administration. Site personnel will provide instructions on what is an acceptable method. Exclusion Criteria: * Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual. * Poor/no collateral circulation in the opinion of the investigator (e.g., collateral score of 0 or 1 if data available). * ASPECT score of 0-4. * Current AIS is being treated with IV thrombolytic therapy (e.g., alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours. * Intent to use any endovascular device that is not Food and Drug Administration (FDA)-approved. * Planned use of intra arterial thrombolytic therapy. * Known severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention. * Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention. * Known arterial condition that would prevent the mechanical device from achieving reperfusion (e.g., aortic dissection, carotid stent). * Subjects with end stage kidney disease. * Part A Cohort 1: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded. Chronic use of anti-platelet drugs is acceptable. * Part A Cohort 2: Subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. Chronic use of anti-platelet drugs is acceptable. * Part A Cohort 3 and Part B: With SRC approval, subjects in Part A Cohort 3 and Part B taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded unless subject has both a STAT international normalized ratio (INR) \< 1.7, and a platelet count \> 100K/µL prior to randomization. (If the SRC does not approve expansion of this criterion, then subjects taking a chronic anticoagulant (e.g., apixaban, warfarin) are excluded, as in Cohort 1. Chronic use of anti-platelet drugs is acceptable in either case.) * Known metastatic malignancy with poor prognosis. * Subjects with any comorbid disease, condition, or situation that would confound the neurologic and functional evaluations, prevent improvement, or render the subject unable to complete follow-up treatment, in the opinion of the investigator. Examples of excluded comorbid conditions include respiratory failure because of pneumonia, chronic diseases with significant disability, or non-ambulatory status. Contact medical monitor for consultation if necessary. * Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion. * Subject was a participant in either SCP CL 0001 or SCP CL 0002 and received scp776, or previously participated in SCP-CL-0003. * Subject is experiencing moderate or severe hypotension as defined by CTCAE criteria (i.e., symptomatic and requiring medical intervention with fluid resuscitation and/or vasopressors) or a confirmed systolic blood pressure less than 90 mmHg.

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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.

Contacts and locations

Locations

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Banner University Medical Center /Univ of Arizona

    Tucson, Arizona, 85719, United States

  • Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona, 85251, United States

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030, United States

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001, United States

  • Lennox Hill Hospital

    New York, New York, 10075, United States

  • Marcus Neuroscience Institute

    Boca Raton, Florida, 33486, United States

  • Medical College of Wisconsin and Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Mercy Health - St Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44504, United States

  • Mercy Health - St Vincent Medical Center

    Toledo, Ohio, 43608, United States

  • Northshore University Hospital

    Manhasset, New York, 11030, United States

  • Oregon Stroke Center at OHSU

    Portland, Oregon, 97239, United States

  • Penn State Health - M.S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Providence St. Vincent Medical Center

    West Haven-Sylvan, Oregon, 97225, United States

  • SSM Health DePaul Hospital

    Bridgeton, Missouri, 63044, United States

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UNM Hospital

    Albuquerque, New Mexico, 87106, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Miami - Jackson Memorial Hospital

    Miami, Florida, 33136, United States

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Other studies related to the condition(s) this trial covers.