Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)
Recruiting now · Phase 1/Phase 2
Conditions studied: Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC), Hemimegalencephaly
In brief
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Key facts
- Study ID
- NCT07287202
- Run by
- Sovargen
- People needed
- 12
- Starts
- 2026-07-14
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Austin Hospital — Heidelberg, Victoria, Australia (enrolling)
- The Alfred — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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