Clinical Trial

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

Recruiting Phase 1/2
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Summary
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Protocol Amendment History 5 changes
critical Recruitment opened 2026-08-11
notable Enrollment reduced: 15 -> 12 participants 2026-08-11
minor Trial arms changed: 1 -> 2 2026-08-11
notable Primary completion pushed: 2026-12 -> 2027-02 2026-08-11
minor Completion moved earlier: 2027-06 -> 2027-03 2026-08-11
Trial Details
NCT Number NCT07287202
Lead Sponsor Sovargen
Conditions Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC), Hemimegalencephaly
Enrollment 12 participants
Start Date 2026-07-14
Primary Completion 2027-02 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-10