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

Study acronym: SESAM
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Dec 16, 2025, no change to tracked fieldsv8-v9
  2. Study Identification, Study Statusv7
  3. Eligibility criteria shortened, about 7 words Site contacts updated at 1 of 13 sitesv6 Show 1 more changeShow less
    • Site contacts updated at 1 of 13 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoint revised Study sites: 1 to 13 · Secondary endpoints expanded, about 125 words · Study description expanded, about 194 words · 2 morev5 Show 5 more changesShow less
    • Study sites: 1 to 13
    • Secondary endpoints expanded, about 125 words
    • Study description expanded, about 194 words
    • Publications: 1 to 3
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 16 to 20 Primary and study completion dates: Sep 2026 to Mar 2027 · Interventions: Alpelisib (BYL719) (Drug), Matching placebo (Drug), Optional lumbar puncture (Procedure) to Alpelisib (BYL719) (Drug), Matching placebo (Drug), Optional lumbar puncture + blood sample (Procedure) · Eligibility criteria revisedv4 Show 3 more changesShow less
    • Primary and study completion dates: Sep 2026 to Mar 2027
    • Interventions: Alpelisib (BYL719) (Drug), Matching placebo (Drug), Optional lumbar puncture (Procedure) to Alpelisib (BYL719) (Drug), Matching placebo (Drug), Optional lumbar puncture + blood sample (Procedure)
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria expanded, about 8 wordsv3 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Aug 2026 to Sep 2026 · Start date changed from estimate of Oct 2022 to Nov 28, 2022 · Site details revisedv2 Show 3 more changesShow less
    • Primary and study completion dates: Aug 2026 to Sep 2026
    • Start date changed from estimate of Oct 2022 to Nov 28, 2022
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov