Purpose:
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate
in infants with refractory partial onset seizures (POS).
Study summary:
This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day)
of topiramate compared with placebo as an adjunct therapy in infants with refractory partial
onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double
blind treatment phase of 20 days, a one year open label extension phase and a posttreatment
(taper and withdrawal) phase. The oral liquid formulation will also be assessed during this
study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25
mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during
the four phases of the study.
Criteria:
Inclusion Criteria:
- 1-24 months, inclusive
- Concurrent 1 or 2 antiepileptic drugs
- Receiving regular enteral feedings
- Weigh between 3.5 and 15 kg
- Clinical or EEG evidence of simple or complex POS
Exclusion Criteria:
- Exclusively breast fed and cannot take medicine by mouth
- Surgically implanted and functioning vagus nerve stimulator
- Renal stones
- Medically uncontrolled illnesses or conditions
- Infantile seizures as a result of a correctable medical condition
- Progressive neurologic disorder
Primary Contact:
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.