drugset / Trial / NCT02358538

Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies

NCT02358538

Phase 2 Completed 30 enrolled Marinus Pharmaceuticals
NaSingle-groupOpen-labelPrevention

Summary

To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.

Timeline

Start
2015-11-06
Primary completion
2018-01-16
Completion
2019-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganaxolone Small molecule 63 mg/kg Oral
Subject Ganaxolone Small molecule 1800 mg Oral

Indications