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An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO With Open-Label Safety Period in Pediatric Subjects With Epilepsy

Trial Profile

An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO With Open-Label Safety Period in Pediatric Subjects With Epilepsy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 May 2025

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At a glance

  • Drugs Diazepam (Primary)
  • Indications Epilepsy; Generalised seizures; Partial epilepsies
  • Focus Pharmacokinetics; Registrational
  • Acronyms Stellina™
  • Sponsors Neurelis

Most Recent Events

  • 16 May 2025 Status changed from active, no longer recruiting to completed.
  • 16 Apr 2025 According to a Neurelis media release, the company presented data on the study at the 53rd Annual Child Neurology Society Meeting in November 2024 in San Diego and Annual American Epilepsy Society Meeting in December 2024 in Los Angeles.
  • 16 Apr 2025 According to a Neurelis media release, the USFDA has approved VALTOCO (diazepam nasal spray) for short-term treatment of seizure clusters (acute repetitive seizures) that are different from a person's normal seizure pattern in people 2 years of age and older.

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