Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Latest Information Update: 18 Oct 2023
At a glance
- Drugs Apinocaltamide (Primary)
- Indications Encephalopathy; Epilepsy
- Focus Therapeutic Use
- Acronyms STEAMBOAT
- Sponsors Idorsia Pharmaceuticals; Neurocrine Biosciences
- 06 Dec 2022 Results published in the Neurocrine Biosciences Media Release.
- 06 Dec 2022 Primary endpoint has not been met. (Ratio of spike-wave index (SWI) during first hour of nonrapid eye movement (NREM) sleep based on centralized video-EEG reading.), according to a Neurocrine Biosciences media release.
- 09 Nov 2022 Status changed from active, no longer recruiting to completed.