A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
The study is a two period (8-10 days/period), incomplete cross-over in which successive
cohorts of 9 subjects are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each
cohort, Sequence A, comprised of 6 subjects, receives ascending doses of ganaxolone during
period 1 and ganaxolone (at the maximal dose attained in period 1) and ascending doses of
placebo during period 2. Sequence B, comprised of 3 subjects, receives ascending doses of
placebo during period 1 and receives the maximum dose of placebo and ascending doses of
ganaxolone during period 2. The dosing level in each subsequent cohort will be based upon
experience gained from previous cohorts.