Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT07287202
Brief Summary:
This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.
Detailed Description:
This is an open-label, phase 1b/2a study to evaluate safety, tolerability, and pharmacokinetics SVG103 (paxalisib) in 15 patients with Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME).
The name of the study drug involved in this study is SVG103 (paxalisib).
The trial consists of two parts: the core phase consists of a 4 week prospective baseline period (D-28\~D1) to collect seizure data, followed by a 12-week treatment phase. The extension phase consists of a 24-week treatment period. For participants not continuing in the extension phase, there is a 4-week washout (follow-up) phase.
It is expected that about 15 participants will take part in this research study for up to 9 months as long as there is no serious side effects and disease progression.
"Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved SVG103 (paxalisib) for this specific disease.
Study:
NCT07287202
Study Brief:
Protocol Section:
NCT07287202