At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 101 enrolled
Drug / intervention
ganaxolone +1 moredrug
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 Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label Treatment
In Brief
A Phase 3 clinical trial evaluating ganaxolone and Placebo for CDKL5 Deficiency Disorder. Completed, enrolled 101 participants across 36 sites in 8 countries.
Detailed Summary
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCDKL5 Deficiency Disorder
CountriesAustralia, France, Israel, Italy, Poland, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJun 2018
Primary CompletionJul 2020
Study CompletionMay 2021
TodayJul 2026
First PostedJun 28, 2018
Enrollment StartJun 30, 2018
Primary CompletionJul 31, 2020
Study CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.0 years ago
Interventions
ganaxolonedrug
active drug
Placebodrug
inactive