Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1)
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|ClinicalTrials.gov Identifier: NCT02930018|
Recruitment Status : Completed
First Posted : October 11, 2016
Results First Posted : December 14, 2020
Last Update Posted : December 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Drug: Nerinetide (NA-1), 2.6 mg/kg Drug: Placebo||Phase 3|
The primary objective is to determine the efficacy of the neuroprotectant, Nerinetide, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization.
The secondary objectives are to determine the efficacy of Nerinetide in:
- Reducing functional dependence
- Improving neurological outcome
- Improving activities of daily living
- Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous (IV) infusion of Nerinetide to subject with acute stroke who are selected for endovascular revascularization on serious adverse events (SAEs) and 90-day mortality.
This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose design. Subjects harboring an acute ischemic stroke and who are selected for endovascular revascularization in accordance with local institutional practices and who harbor a small established infarct core and with good collateral circulation will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of Nerinetide (NA-1) or placebo as soon as they are deemed to have met the enrollment criteria and with the intention of starting administration within 30 minutes of randomization. The randomization will be by stochastic minimization to balance baseline factors.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||November 20, 2019|
|Actual Study Completion Date :||November 20, 2019|
Placebo Comparator: Placebo
Drug vehicle only
Placebo Comparator: Placebo
Other Name: Drug vehicle only
|Experimental: Nerinetide (NA-1), 2.6 mg/kg||
Drug: Nerinetide (NA-1), 2.6 mg/kg
Single intravenous infusion of nerinetide over 10 ± 1 minutes
Other Name: NA-1
- Number of Subjects With mRS Score of 0 to 2 [ Time Frame: 90 Days ]
Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS.
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
- Number of Subjects With NIHSS Score of 0 to 2 [ Time Frame: 90 Days or the last rating ]
Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating.
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.
- Mortality Rate [ Time Frame: 90 Days ]Mortality rate, as defined by event rate (%) for mortality over the 90-day study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930018
|Principal Investigator:||Michael D Hill, MD MSc||University of Calgary|