NCT02315443

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous NA-1 Initiated by Paramedics in the Field for Acute Cerebral Ischemia Within Three Hours of Symptom Onset

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: NoNO Inc. · Industry
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Cerebral Ischemia

Interventions

Type	Name	Description
DRUG	Nerinetide (NA-1)
DRUG	Placebo

Timeline

• Start date: 2015-03-26
• Primary completion: 2023-03-27
• Completion: 2023-03-27
• First posted: 2014-12-11
• Last updated: 2023-05-12

Locations

4 sites across 1 country: Canada