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

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).

Start Date06 Dec 2020

Sponsor / Collaborator

NoNO, Inc.

[+1]

NCT02056574 / WithdrawnPhase 2

Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms

This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.

Start Date01 Nov 2015

Sponsor / Collaborator

NoNO, Inc.

NCT02315443 / CompletedPhase 3

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

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.

Start Date26 Mar 2015

Sponsor / Collaborator

NoNO, Inc.

[+7]

100 Clinical Results associated with Nerinetide

100 Translational Medicine associated with Nerinetide

100 Patents (Medical) associated with Nerinetide

Literatures (Medical) associated with Nerinetide

01 Jul 2024·JAMA Neurology

Time From Hospital Arrival Until Endovascular Thrombectomy and Patient-Reported Outcomes in Acute Ischemic Stroke

Article

Author: Ashutosh, Jadhav ; Donald F, Frei ; Alexandre Y, Poppe ; Oh Young, Bang ; Ryan A, McTaggart ; Rishi, Gupta ; George A, Lopez ; Marie-Christine, Camden ; Sauvageau, Eric ; Silver, Frank L. ; Nogueira, Raul G. ; Thalia S, Field ; Brian H, Buck ; Chang-Hyun, Kim ; Andrew M, Demchuk ; Field, Thalia S. ; Hana, Choe ; Stephn J, Phillips ; Kennth S, Butcher ; Joseph L, Schindler ; Shah, Ruchir ; Cameron G, McDougall ; Puetz, Volker ; Goyal, Mayank ; John, Thornton ; Demchuk, Andrew M. ; Simon, Nagel ; Sahlas, Jim ; Michael E, Kelly ; Michael, Mayich ; Ruchir A, Shah ; Dar, Dowlatshahi ; Brian A, van Adel ; Frank L, Silver ; Demetrios J, Sahlas ; David T, Parrella ; McTaggart, Ryan A. ; Rempel, Jeremy L. ; Richard H, Swartz ; Götz, Thomalla ; Swartz, Richard ; Aditya, Bharatha ; Campbell, Bruce ; Bijoy K, Menon ; Mayank, Goyal ; Dowlatshahi, Dar ; Daniel, Roy ; Tymianski, Michael ; Staffan, Holmin ; Poppe, Alexandre Y. ; Hill, Michael D. ; Jason W, Tarpley ; Marios-Nikos, Psychogios ; Sean, Murphy ; Donald, Heck ; Volker, Puetz ; Coleman O, Martin ; René, Chapot ; Michael D, Hill ; Bruce CV, Campbell ; Sidney, Starkman ; Chapot, René ; Joung-Ho, Rha ; Smith, Eric E. ; Raul, Nogueira ; Joundi, Raed A. ; Ronald F, Budzik ; Ganesh, Aravind ; Jennifer L, Mandzia ; Sung-Il, Sohn ; Timothy J, Kleinig ; Ajit S, Puri ; Ji Heo, Heo ; Paul A, Burns ; Eric, Sauvageau ; Joey D, English ; Jeanne, Teitelbaum

ImportanceThe time-benefit association of endovascular thrombectomy (EVT) in ischemic stroke with patient-reported outcomes is unknown.ObjectiveTo assess the time-dependent association of EVT with self-reported quality of life in patients with acute ischemic stroke.Design, Setting, and ParticipantsData were used from the Safety and Efficacy of Nerinetide in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) trial, which tested the effect of nerinetide on functional outcomes in patients with large vessel occlusion undergoing EVT and enrolled patients from March 1, 2017, to August 12, 2019. The ESCAPE-NA1 trial was an international randomized clinical trial that recruited patients from 7 countries. Patients with EuroQol 5-dimension 5-level (EQ-5D-5L) index values at 90 days and survivors with complete domain scores were included in the current study. Data were analyzed from July to September 2023.ExposureHospital arrival to arterial puncture time and other time metrics.Main Outcomes and MeasuresEQ-5D-5L index scores were calculated at 90 days using country-specific value sets. The association between time from hospital arrival to EVT arterial-access (door-to-puncture) and EQ-5D-5L index score, quality-adjusted life years, and visual analog scale (EQ-VAS) were evaluated using quantile regression, adjusting for age, sex, stroke severity, stroke imaging, wake-up stroke, alteplase, and nerinetide treatment and accounting for clustering by site. Using logistic regression, the association between door-to-puncture time and reporting no or slight symptoms (compared with moderate, severe, or extreme problems) was determined in each domain (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) or across all domains. Time from stroke onset was also evaluated, and missing data were imputed in sensitivity analyses.ResultsAmong 1105 patients in the ESCAPE-NA1 trial, there were 1043 patients with EQ-5D-5L index values at 90 days, among whom 147 had died and were given a score of 0, and 1039 patients (mean [SD] age, 69.0 [13.7] years; 527 male [50.7%]) in the final analysis as 4 did not receive EVT. There were 896 survivors with complete domain scores at 90 days. There was a strong association between door-to-puncture time and EQ-5D-5L index score (increase of 0.03; 95% CI, 0.02-0.04 per 15 minutes of earlier treatment), quality-adjusted life years (increase of 0.29; 95% CI, 0.08-0.49 per 15 minutes of earlier treatment), and EQ-VAS (increase of 1.65; 95% CI, 0.56-2.72 per 15 minutes of earlier treatment). Each 15 minutes of faster door-to-puncture time was associated with higher probability of no or slight problems in each of 5 domains and all domains concurrently (range from 1.86%; 95% CI, 1.14-2.58 for pain or discomfort to 3.55%; 95% CI, 2.06-5.04 for all domains concurrently). Door-to-puncture time less than 60 minutes was associated higher odds of no or slight problems in each domain, ranging from odds ratios of 1.49 (95% CI, 1.13-1.95) for pain or discomfort to 2.59 (95% CI, 1.83-3.68) for mobility, with numbers needed to treat ranging from 7 to 17. Results were similar after multiple imputation of missing data and attenuated when evaluating time from stroke onset.Conclusions and RelevanceResults suggest that faster door-to-puncture EVT time was strongly associated with better health-related quality of life across all domains. These results support the beneficial impact of door-to-treatment speed on patient-reported outcomes and should encourage efforts to improve patient-centered care in acute stroke by optimizing in-hospital processes and workflows.

01 Jun 2024·Clinical Neuroradiology

Analysis of the ESCAPE-NA1 Trial

Article

Author: Ospel, Johanna M ; Singh, Nishita ; McTaggart, Ryan A ; Goyal, Mayank ; Marko, Martha ; Nogueira, Raul G ; Uchida, Kazutaka ; Hill, Michael D ; Poppe, Alexandre Y ; Menon, Bijoy K ; Almekhlafi, Mohammed A ; Rempel, Jeremy L ; Demchuk, Andrew M ; Tymianski, Michael

AbstractPurposeNon-stenotic (< 50%) carotid disease may play an important etiological role in ischemic stroke classified as embolic stroke of undetermined source (ESUS). We aimed to assess the prevalence of non-stenotic carotid disease and its association with ipsilateral ischemic stroke.MethodsData are from ESCAPE-NA1, a randomized controlled trial investigating the neuroprotectant nerinetide in patients with acute ischemic stroke and large vessel occlusion (LVO). The degree of stenosis of the extracranial internal carotid artery (ICA) and high-risk plaque features were assessed on baseline computed tomography (CT) angiography. We evaluated the association of non-stenotic carotid disease and ipsilateral stroke by age-adjusted and sex-adjusted logistic regression and calculated the attributable risk of ipsilateral stroke caused by non-stenotic carotid disease.ResultsAfter excluding patients with non-assessable imaging, symptomatic > 50% carotid stenosis and extracranial dissection, 799/1105 (72.1%) patients enrolled in ESCAPE-NA1 remained for this analysis. Of these, 127 (15.9%) were classified as ESUS. Non-stenotic carotid disease occurred in 34/127 ESUS patients (26.8%) and was associated with the presence of ipsilateral ischemic stroke (odds ratio, OR 1.6, 95% confidence interval, CI 1.0–2.6, p = 0.049). The risk of ipsilateral ischemic stroke attributable to non-stenotic carotid disease in ESUS was estimated to be 19.7% (95% CI −5.7% to 39%), the population attributable risk was calculated as 4.3%. Imaging features such as plaque thickness, plaque irregularity or plaque ulceration were not different between non-stenotic carotids with vs. without ipsilateral stroke.ConclusionNon-stenotic carotid disease frequently occurs in patients classified as ESUS and is associated with ipsilateral ischemic stroke. Our findings support the role of non-stenotic carotid disease as stroke etiology in ESUS, but further prospective research is needed to prove a causal relationship.

01 Jun 2024·Neuropharmacology

Tat-NR2B9c attenuates oxidative stress via inhibition of PSD95-NR2B-nNOS complex after subarachnoid hemorrhage in rats

Article

Author: Fang, Yuanjian ; He, Yezhao ; Zhang, Zeyu ; Wang, Kaikai ; Zhang, Haocheng ; Zhang, Anke ; Liu, Yibo ; Wang, Xiaoyu ; Chen, Sheng ; Yu, Qian ; Xu, Longbiao ; Zhang, Jiahao

Oxidative stress plays important roles in the pathogenesis of early brain injury (EBI) after subarachnoid hemorrhage (SAH). Tat-NR2B9c has shown efficacy as a neuroprotective agent in several studies. Here, we identified the neuroprotective role of Tat-NR2B9c after SAH and its related mechanisms. The results showed that Tat-NR2B9c treatment attenuated oxidative stress, therefore alleviated neuronal apoptosis and neurological deficits after SAH. Tat-NR2B9c treatment could alleviate mitochondrial vacuolization induced by SAH. Compared to SAH + vehicle group, Tat-NR2B9c resulted in the decrease of Acetylated superoxide dismutase2 (Ac-SOD2), Bcl-2-associated X protein (Bax) and cleaved-caspase3 (CC3) protein expression, and the up-regulation of Sirtunin 3 (Sirt3) and Bcl-2 protein level. Moreover, Tat-NR2B9c attenuated excitotoxicity by inhibiting the interaction of PSD95-NR2B-nNOS. Our results demonstrated that Tat-NR2B9c inhibited oxidative stress via inhibition of PSD95-NR2B-nNOS complex formation after SAH. Tat-NR2B9c may serve as a potential treatment for SAH induced brain injury.

100 Deals associated with Nerinetide

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D11729	-	-	DB12595

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 3	CA	NoNO, Inc.	01 Mar 2017
Acute Ischemic Stroke	Phase 3	DE	NoNO, Inc.	01 Mar 2017
Acute Ischemic Stroke	Phase 3	US	NoNO, Inc.	01 Mar 2017
Acute Ischemic Stroke	Phase 3	AU	NoNO, Inc.	01 Mar 2017
Brain Ischemia	Phase 3	CA	NoNO, Inc.	26 Mar 2015
Acute Ischemic Stroke	Phase 2	KR	NoNO, Inc.	01 Mar 2017
Acute Ischemic Stroke	Phase 2	IE	NoNO, Inc.	01 Mar 2017
Acute Ischemic Stroke	Phase 2	GB	NoNO, Inc.	01 Mar 2017
Acute Ischemic Stroke	Phase 2	SE	NoNO, Inc.	01 Mar 2017
Aneurysm	Phase 2	CA	NoNO, Inc.	01 Aug 2008

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESCAPE NA1-Trial (ISC2021)	Not Applicable	Stroke \| occlusions	1,105	Nerinetide	pjollirtkf(vzdzsvpnma) = wsdamssgla nidzmmvqdt (pyxwiigxji )	-	01 Mar 2021
				Placebo	pjollirtkf(vzdzsvpnma) = qtodocesfk nidzmmvqdt (pyxwiigxji )
NCT00728182 (ENACT, CTgov)	Phase 2	Stroke \| Aneurysm	185	NA-1 (1 NA-1)	ljhmaujdhv(bdztpxivzr) = fzwrryuysc fcierolvvo (pclhxluaro, rlkqthhqyw - ckxkbngglk) View more	-	17 Oct 2013
				placebo (2 Placebo)	ljhmaujdhv(bdztpxivzr) = wgloqcxpnv fcierolvvo (pclhxluaro, dkujrxbker - bvtczjgqtf) View more

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