Study of the Safety and Neuroprotective Capacity of Scp776 in Acute Ischemic Stroke

About

Brief Summary

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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 middle cerebral artery.
Onset of AIS (last time subject seen well) to randomization is ≤16 hours.
Intended endovascular treatment with an approved endovascular device.

Exclusion Criteria:

Evidence of acute intra-cerebral hemorrhage on qualifying imaging, per radiology lab manual.
Poor/no collateral circulation. (e.g. collateral score of 0 or 1).
ASPECT score of 0-4.
Current AIS is being treated with IV thrombolytic therapy (eg, alteplase, tenecteplase), or the subject has received thrombolytic therapy within the previous 24 hours.
Intent to use any endovascular thrombectomy device that is not 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 (eg, aortic dissection, carotid stent).
Subjects with end-stage kidney disease.
Subjects taking a chronic anticoagulant (eg, warfarin, apixaban).
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.
Participation in another clinical trial of an FDA-unapproved therapeutic device or drug in the 30 days preceding study inclusion.
Subject has previously received scp776 in another clinical trial.