Status: Not yet recruiting
Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Participants needed: 15
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: SovargenUpdated: Dec 23, 2025Locations: 2
Eligibility criteria
FCD-II: diagnosis of FCD Type II based on clinical symptoms and confirmed by a p... [+8]
Clinically significant hepatic, renal, pulmonary, gastrointestinal, neurological... [+8]