A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms

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.

Timeline

Start

2007-01

Primary completion

2008-05

Completion

2008-05

Drugs

Indications