Field Randomization of Nerinetide (NA-1) Therapy in Early Responders

NoNO Inc.532 enrolled

Overview

The purpose of this study is to determine whether nerinetide (NA-1) is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.

Nerinetide (NA-1) is being developed as an emergency drug aimed at reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset. The primary objective is to determine the efficacy of nerinetide in reducing global disability in patients with acute stroke. The secondary objectives are to determine the efficacy of nerinetide in reducing functional dependence, reducing mortality rate, reducing worsening of stroke, improving neurological outcome and improving activities of daily living. The leading safety objectives are to determine the effect of administering a target dose of 2.60 mg/kg (up to a maximum dose of 270 mg) IV infusion of nerinetide within three hours of symptom onset by paramedics in the field on serious adverse events and 90-day mortality. This trial is a multicenter, randomized, double-blind, placebo-controlled, single dose study initiated prehospital in the ambulance. It is being conducted using Emergency Medical Services (EMS) in Canada. Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system, and further screened for eligibility and approval by an on-call trial physician. The paramedics will administer the study drug. Upon arrival at the emergency department, subjects will receive standard-of-care. An Independent Data Monitoring Committee will perform safety reviews of the clinical data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

532

Conditions

Acute Cerebral Ischemia

Interventions

Nerinetide (NA-1)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provisional diagnosis of acute stroke as identified by paramedics using the local stroke triage tool * Respiratory rate 12-24 breaths per minute * Oxygen saturation ≥ 90% on room air * Systolic blood pressure \< 90 or \> 220 mmHg * Weight 45-120 kg * Last seen in usual state of health less than 3 hours before anticipated study drug initiation * Independently ambulatory with or without devices prior to event * LAMS score of 2-5 for at least 15 minutes and remains 2-5 at time of randomization Exclusion Criteria: * Lack of IV access * Canadian Triage and Acuity Scale Level 1 and/or uncorrected airway, breathing or significant circulatory problem * Blood sugar \< 3 mmol/L (\< 55 mg/dL) * Seizure at onset of symptoms or observed by paramedic * Glasgow coma score of \<10 * Major head trauma in the last three months * Recent stroke in the last three months * Known or presumptive signs of pregnancy or breastfeeding * Prisoner * Long term care facility resident * Known advance directive to not resuscitate * Known participation in a clinical trial with an investigational drug or device within 30 days preceding this trial * Pre-existing neurologic, psychiatric, or advanced systemic condition that would preclude obtaining the neurological or functional outcome evaluations

Locations (4)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

British Columbia Ambulance Service and British Columbia Emergency Health Services

Vancouver, British Columbia, Canada

Vancouver General Hospital, Vancouver Coastal Health

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Modified Rankin Scale (mRS) scale

The percentage of responders, using a sliding dichotomy on the mRS

Time frame: 90 days

Secondary Outcomes

mRS shift analysis

Shift to reduced functional dependence analyzed across the whole distribution of scores on the mRS

Time frame: 90 Days or the last rating

Mortality rate

A reduction in mortality as defined by event rate (proportion, expressed as a percentage)

Time frame: 90 Days

Worsening of stroke rate

A reduction in proportion of participants with worsening of stroke. Worsening of stroke is defined as progression, or hemorrhagic transformation, of the index stroke as documented in the study CRF that (i) is deemed life-threatening and/or (ii) results in increased disability as gauged by a ≥4 point increase from lowest NIHSS during hospitalization and/or (iii) results in death.

Time frame: 90 Days

National Institutes of Health Stroke Scale (NIHSS)

Proportion of subjects with good neurological outcome, as defined by a score of 0-1 on the NIHSS

Time frame: 90 Days or the last rating

Barthel Index

Proportion of subjects with functional independence in activities of daily living, as defined by a score of ≥ 95 on the Barthel Index

Time frame: 90 Days or the last rating

Data from ClinicalTrials.gov

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