At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 850 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Nerinetide 2.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
In Brief
A Phase 3 clinical trial evaluating Placebo and Nerinetide for Stroke, Acute. Completed, enrolled 850 participants across 81 sites in 9 countries.
Detailed Summary
The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Acute
CountriesAustralia, Canada, Germany, Italy, Netherlands, Norway, Singapore, Switzerland, United States
CollaboratorsUniversity of Calgary
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartDec 2020
Primary CompletionAug 2023
TodayJul 2026
First PostedJul 8, 2020
Enrollment StartDec 6, 2020
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.0 years ago
Interventions
Placebodrug
Vehicle only
Nerinetidedrug
Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes