Expired Study
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Loxahatchee, Florida


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


NCT ID:

NCT00113815


Primary Contact:

Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


Backup Contact:

N/A


Location Contact:

Loxahatchee, Florida
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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