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

U.S., Dec. 18 -- ClinicalTrials.gov registry received information related to the study (NCT07287202) titled 'Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)' on Dec. 11.

Brief Summary: This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.

Study Start Date: March, 2026

Study Type: INTERVENTIONAL

Condition: Focal Cortical Dysplasia Tuberous Sclerosis Complex (TSC) Hemimegalencephaly

Intervention: DRUG: SVG103

The study treatment is administered for 3 months during the core phase and for an additional 6 months during the extension phas...