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

Acute Ischemic Stroke (AIS) Clinical Trial

— ARPEGGIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585606
• Other study ID #: SCP-CL-0003
• Status: Recruiting
• Phase: Phase 2
• Start date: October 19, 2022
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Silver Creek Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a Phase 2 randomized, placebo-controlled, double-blind study that will be conducted in 2 parts: sequential dose escalation in Part A, followed by dose expansion in Part B. In Part A, approximately 40 evaluable subjects will be assigned 1:1:2 overall to Cohort 1, Cohort 2 or placebo. Doses of scp776 will be tested sequentially in 2 cohorts, each in parallel with a volume-matched placebo randomized as 1:1 scp776:placebo within each cohort, to maintain the overall 1:1:2 ratio. Subjects will receive doses of either normal saline (placebo) or scp776, approximately 24 hours apart.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke (AIS)
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Placebo
Volume Matched Placebo
• scp776 (1.9 mg/kg)
Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 1.9 mg/kg
• scp776 (3.8 mg/kg)
Cohort 1 dose regimen: Intravenous (IV) slow injection(s) over 2 minutes - 3.8 mg/kg

Locations

Country	Name	City	State
United States	Jefferson Abington Hospital	Abington	Pennsylvania
United States	UNM Hospital	Albuquerque	New Mexico
United States	Augusta University Medical Center	Augusta	Georgia
United States	Marcus Neuroscience Institute	Boca Raton	Florida
United States	SSM Health DePaul Hospital	Bridgeton	Missouri
United States	The Ohio State University	Columbus	Ohio
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Northshore University Hospital	Manhasset	New York
United States	Lennox Hill Hospital	New York	New York
United States	Oregon Stroke Center at OHSU	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	HonorHealth Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	Providence St. Vincent Medical Center	W. Haven-Sylvan	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Silver Creek Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NIHSS from baseline to Day 7 or at hospital discharge (whichever occurs first).	Change from baseline in NIHSS will be assessed with Analyses of Variance performed on the FAS and PPAS. Terms to be included in the model are baseline NIHSS, treatment, and ASPECT score (ASPECT score =6 versus ASPECT score >6).	Baseline to Day 7 or at hospital discharge (whichever occurs first).
Secondary	Change in NIHSS from baseline to Day 3		Baseline through Day 3
Secondary	Change in Modified Rankin Scale score at Day 30 from baseline		Baseline through Day 30
Secondary	Change in Modified Rankin Scale score at Day 90 from baseline		Baseline through Day 90
Secondary	Change in NIHSS from baseline to Day 1		Baseline through Day 1
Secondary	Change in NIHSS from baseline to Day 2		Baseline through Day 2
Secondary	Change in Barthel Index score at Day 90 from baseline		Baseline through Day 90