A Phase II Double-blind Multi-center, Placebo-controlled Trial, to Assess the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)
Latest Information Update: 22 May 2025
At a glance
- Drugs Alpelisib (Primary)
- Indications Brain disorders; Neonatal-disorders
- Focus Therapeutic Use
- Acronyms SESAM
Most Recent Events
- 22 Sep 2023 Planned number of patients changed from 16 to 20.
- 22 Sep 2023 Planned End Date changed from 1 Sep 2026 to 1 Mar 2027.
- 22 Sep 2023 Planned primary completion date changed from 1 Sep 2026 to 1 Mar 2027.