A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
Completed
Marinus Pharmaceuticals
Phase 2
2007-01-01
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.
A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
Completed
Marinus Pharmaceuticals
Phase 2
2007-02-01
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -
on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic
medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females
with catamenial epilepsy.
Catamenial epilepsy refers to a relationship between seizure frequency and a woman's
menstrual cycle, where the number of seizures increases around the time of a woman's
menstrual cycle.
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