Clinical Trial

Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)

Study acronym: SESAM
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study is a two periods multi-center Phase II trial, with a 6 months double-blind, placebo-controlled period followed by open label period, to assess the efficacy and safety of alpelisib (BYL719) in pediatric and adult patients with Megalencephaly-CApillary malformation Polymicrogyria syndrome (MCAP)
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-10-10; most recent amendment 2026-02-23.
Status change: Not Yet Recruiting → Recruiting 2022-11-29
Trial Details
NCT Number NCT05577754
Lead Sponsor Centre Hospitalier Universitaire Dijon
Collaborators: Novartis Pharmaceuticals
Conditions Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)
Enrollment 20 participants
Start Date 2022-11-28
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-24