At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 57 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, Placebo-controlled, Dose-ranging Clinical Study to Evaluate the Safety, Tolerability, and Antiepileptic Activity of Ganaxolone in Treatment of Patients With Infantile Spasms
In Brief
A Phase 2 clinical trial evaluating Ganaxolone and Placebo for Infantile Spasms. Completed, enrolled 57 participants across 15 sites.
Detailed Summary
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of placebo and ascending doses of ganaxolone. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfantile Spasms
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedMar 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedMar 1, 2007
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.3 years ago
Interventions
Ganaxolonedrug
Placeboother