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

NoNO Inc.

Status and phase: Completed; Phase 3

Conditions: Acute Cerebral Ischemia

Treatments: Drug: Placebo; Drug: Nerinetide (NA-1)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02315443

NA-1-005

HC6-24-c 195121 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 532 patients

Sex: All

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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532 participants in 2 patient groups, including a placebo group

Nerinetide (NA-1)

Experimental group

Description:

2.60 mg/kg of nerinetide (up to a maximum dose of 270 mg) administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.

Treatment:

Drug: Nerinetide (NA-1)

Placebo

Placebo Comparator group

Description:

Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.

Treatment:

Drug: Placebo