Acute ischemic stroke (AIS) MedDRA version: 22.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1 Level: LLT Classification
Conditions
Interventions
Product Name: Nerinetide
Product Code: NA-1
Pharmaceutical Form: Injection
INN or Proposed INN: Nerinetide
CAS Number: 500992-11-0
Current Sponsor code: NA-1/Tat-NR2B9c
Other descriptive name: Nerinet
Sponsors
NoNO Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy of the neuroprotectant, nerinetide in: • Reducing global disability in participants with acute ischemic stroke (AIS);Secondary Objective: The secondary objectives are to determine the efficacy of nerinetide in: 1) Reducing mortality rate 2) Reducing worsening of stroke* 3) Reducing functional dependence 4) Improving neurological outcome * Worsening of stroke is defined as (A) progression, or hemorrhagic transformation of the index stroke, as documented by medical imaging that is (a) life-threatening requiring intervention and/or (b) results in increased disability as gauged by a =4 point increase from lowest NIHSS during hospitalization or (B) results in death from the index stroke.;Primary end point(s): Reducing global disability in participants with acute ischemic stroke (AIS). The proportion of participants with independent functioning on the modified Rankin Scale (mRS), as defined by a score of 0-2 at Day 90.;Timepoint(s) of evaluation of this end point: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) A reduction in mortality rate, as defined by event rate (proportion, expressed as a percentage) for mortality over the 90-day study period. 2) Proportion of participants with worsening of stroke over the 90-day study period. 3) A shift of one or more categories to reduced functional dependence analyzed across the whole distribution of outcomes on the mRS at Day 90 post randomization. 4) Proportion of participants with good neurological outcome, as defined by a score of 0-2 on the NIHSS at Day 90 post randomization.;Timepoint(s) of evaluation of this end point: Day 90 | — |
Countries
Australia, Canada, Germany, Italy, Netherlands, Norway, Singapore, Switzerland, United States
Contacts
Public ContactYatika Kohli
NoNO Inc.
Outcome results
None listed