A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms
Phase of Trial: Phase III
Latest Information Update: 17 Dec 2018
At a glance
- Drugs Cannabidiol (Primary) ; Vigabatrin
- Indications Infantile spasms
- Focus Registrational; Therapeutic Use
- Sponsors INSYS Therapeutics, Inc
- 17 Dec 2018 According to an INSYS Therapeutics, Inc. media release, enrollment in the study of infantile spasms has occurred at a slower pace than anticipated, and the company will provide an update once it has better visibility into enrollment.
- 15 Aug 2018 Planned End Date changed from 1 Jan 2019 to 1 Dec 2019.
- 15 Aug 2018 Planned primary completion date changed from 1 Oct 2018 to 1 Dec 2019.