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
Outcome
Missed primary endpoint
registry analysis (superiority test); Cohort 1: Sequence A: Ganaxolone/Placebo/Ganaxolone vs Cohort 1: Sequence B: Placebo/Ganaxolone/Placebo; p = 0.7391; ANCOVA NCT00441896 ↗
registry analysis (superiority test); Cohort 2: Sequence A: Ganaxolone/Placebo/Ganaxolone vs Cohort 2: Sequence B: Placebo/Ganaxolone/Placebo; p = 0.5370; ANCOVA NCT00441896 ↗
registry analysis (superiority test); Cohort 3: Sequence A: Ganaxolone/Placebo/Ganaxolone vs Cohort 3: Sequence B: Placebo/Ganaxolone/Placebo; p = 0.9080; ANCOVA NCT00441896 ↗
registry analysis (superiority test); Cohort 4: Sequence A: Ganaxolone/Placebo/Ganaxolone vs Cohort 4: Sequence B: Placebo/Ganaxolone/Placebo; p = 0.2539; ANCOVA NCT00441896 ↗
registry analysis (superiority test); Cohort 5: Sequence A: Ganaxolone/Placebo/Ganaxolone vs Cohort 5: Sequence B: Placebo/Ganaxolone/Placebo; p = 0.6657; ANCOVA NCT00441896 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganaxolone | Small molecule | — | — |