A study to test if a single dose of nerinetide can reduce neurological disability in people who have had a stroke and who are selected for endovascular therapy (a procedure using a device that removes the blood clot (thrombus) from a blood vessel in the brain)

Phase 1

• Conditions: Acute ischemic stroke (AIS); MedDRA version: 22.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 22.1Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 22.1Level: LLTClassification code 10074321Term: Nonhaemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 22.1Level: LLTClassification code 10074318Term: Nonhemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-002360-30-NO
• Lead Sponsor: oNO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-10
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

1) Acute ischemic stroke (AIS) selected for emergency endovascular treatment
2) Age 18 years or greater
3) Onset (last-known-well) time to randomization time within 12 hours
4) Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
a. NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
b. NIHSS > 10 for M2-MCA occlusion
5) Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted
6) Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) = 95. Patient must be living without requiring nursing care
7) Qualifying imaging performed less than 2 hours prior to randomization
8) Consent process completed as per national laws and regulation and the applicable ethics committee requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 510

Exclusion Criteria

1) Treated with a tissue plasminogen activator (e.g., alteplase or tenecteplase) within 24 hours before randomization
2) Planned treatment with a plasminogen activator (intravenous or intra-arterial)
3) Large core of established infarction defined as ASPECTS 0-4
4) Absent or poor collateral circulation on qualifying imaging (e.g. Collateral score of 0 or 1)
5) Any intracranial hemorrhage on the qualifying imaging
6) Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority
7) Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure
8) Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention
9) Estimated or known weight > 120 kg (264 lbs)
10) Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (ß-hCG) test, or breastfeeding
11) Known prior receipt of nerinetide for any reason, including prior enrolment in this ESCAPE-NEXT trial
12) Severe known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis)
13) Severe or fatal comorbid illness that will prevent improvement or follow up
14) Inability to complete follow-up treatment to Day 90
15) Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified