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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Silver Creek Pharmaceuticals

Criteria

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.