At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Ganaxolonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies Followed by 52 Week Open-Label Treatment
In Brief
A Phase 2 clinical trial evaluating Ganaxolone for Epilepsy. Completed, enrolled 30 participants across 10 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesItaly, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartNov 2015
Primary CompletionJan 2018
Study CompletionJan 2019
TodayJul 2026
First PostedFeb 9, 2015
Enrollment StartNov 6, 2015
Primary CompletionJan 16, 2018
Study CompletionJan 4, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.4 years ago
Interventions
Ganaxolonedrug
oral suspension or capsules