drugset / Trial / NCT02315443
Field Randomization of Nerinetide (NA-1) Therapy in Early Responders
Phase 3
Completed
532 enrolled
NoNO Inc.
Brain Canada · collabCanadian Stroke Network · collabDjavad Mowafaghian Centre for Brain Health · collabGenome British Columbia · collabUniversity of British Columbia · collabUniversity of Calgary · collabUniversity of Toronto · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2015-03-26
- Primary completion
- 2023-03-27
- Completion
- 2023-03-27
Outcome
Missed primary endpoint
paper Overall, 145 (57%) of 254 participants in the nerinetide group and 147 (58%) of 253 in the placebo group had the primary outcome PMID 39955120 ↗
paper Prehospital nerinetide did not improve neurological functional outcomes in all patients with suspected ischaemic stroke in the mITT population. PMID 39955120 ↗
Publications
- Christenson J, Hill MD, Swartz RH, Adams C, Benavente O, Casaubon LK, Cheskes S, Ganesh A, Garman JD, Harris C, Harris DR, Heard K, Jenneson S, Kohli Y, Leroux M, Mayor-Nunez D, Medvedev G, Mehdiratta M, Morrison LJ, Ospel JM, Pennington S, Perez Y, Selchen D, Stebner A, Tallon J, Tkach A, Verbeek PR, Tymianski M. Efficacy and safety of intravenous nerinetide initiated by paramedics in the field for acute cerebral ischaemia within 3 h of symptom onset (FRONTIER): a phase 2, multicentre, randomised, double-blind, placebo-controlled study. Lancet. 2025 Feb 15;405(10478):571-582. doi: 10.1016/S0140-6736(25)00193-X.
- Fladt J, Ospel JM, Singh N, Saver JL, Fisher M, Goyal M. Optimizing Patient-Centered Stroke Care and Research in the Prehospital Setting. Stroke. 2023 Sep;54(9):2453-2460. doi: 10.1161/STROKEAHA.123.044169. Epub 2023 Aug 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nerinetide | Peptide | 2.6 mg/kg | — |