Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

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).

Timeline

Start

2020-12-06

Primary completion

2023-08-31

Completion

2023-08-31

Outcome

Missed primary endpoint

paper odds ratio 0·97, 95% CI 0·72-1·30; p=0·82 PMID 39955119 ↗

paper While nerinetide did not improve outcomes in patients with acute ischaemic stroke PMID 39955119 ↗

Publications

• Hill MD, Goyal M, Demchuk AM, Menon BK, Field TS, Guest WC, Berrouschot J, Bormann A, Pham M, Haeusler KG, Dippel DWJ, van Doormaal PJ, Dorn F, Bode FJ, van Adel BA, Sahlas DJ, Swartz RH, Da Costa L, Ospel JM, McDonough RV, Ryckborst KJ, Almekhlafi MA, Heard KJ, Garman DJ, Adams C, Kohli Y, Schoon BA, Buck BH, Muto M, Zafar A, Schneider H, Grossberg JA, Yeo LLL, Tarpley JW, Psychogios MN, Coutinho JM, Limbucci N, Puetz V, Kelly ME, Campbell BCV, Poli S, Poppe AY, Shankar JJ, Chandra R, Dowlatshahi D, Lopez GA, Cirillo L, Moussaddy A, Devlin M, Garcia-Bermejo P, Mandzia JL, Skjelland M, Aamodt AH, Silver FL, Kleinig TJ, Pero G, Minnerup J, McTaggart RA, Puri AS, Chiu AHY, Reimann G, Gubitz GJ, Camden MC, Lee SK, Sauvageau E, Mundiyanapurath S, Frei DF, Choe H, Rocha M, Gralla J, Bailey P, Fischer S, Liebig T, Dimitriadis K, Gandhi D, Chapot R, Jin A, Hassan AE, Zwam WV, Maier IL, Wiesmann M, Niesen WD, Advani R, Eltoft A, Asdaghi N, Murphy C, Remonda L, Ghia D, Jansen O, Holtmannspoetter M, Hellstern V, Witt K, Fromme A, Nimjee SM, Turkel-Parella D, Michalski D, Maegerlein C, Tham CH, Tymianski M; ESCAPE-NEXT Investigators. Efficacy and safety of nerinetide in acute ischaemic stroke in patients undergoing endovascular thrombectomy without previous thrombolysis (ESCAPE-NEXT): a multicentre, double-blind, randomised controlled trial. Lancet. 2025 Feb 15;405(10478):560-570. doi: 10.1016/S0140-6736(25)00194-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nerinetide	Peptide	2.6 mg/kg	Intravenous

Indications