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Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)

StatusRecruiting
PhasePhase 1/2
SponsorSovargen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Dec 2026 → Feb 2027
Enrollment reduced 20% 15 → 12 participants
See other at-risk trials from Sovargen

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment openedv3 Show 8 more changesShow less
    • Start date changed from estimate of Mar 2026 to Jul 14, 2026
    • Primary completion pushed from Dec 2026 to Feb 2027
    • Enrollment reduced: 15 → 12 participants
    • Study completion moved earlier from Jun 2027 to Mar 2027
    • Trial arms changed: 1 → 2
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 23 words
    • Site details revised at 2 of 2 sites
  2. Study Status, Contacts/Locationsv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sovargen
1 trial monitored
See 1 trial at risk
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Trial Details
NCT Number NCT07287202
Lead Sponsor Sovargen
Conditions
(from sponsor)		 Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC), Hemimegalencephaly
Related terms Focal Cortical Dysplasia, Hemimegalencephaly, Tuberous Sclerosis
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov