Topiramate as Adjunctive Therapy in Infants 1-23 Months for the Control of Partial Onset Seizures

Condition(s) targeted: Partial Seizure Disorder; Epilepsy; Seizures

Intervention: topiramate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-23 Months of Age, Inclusive) With Refractory Partial-Onset Seizures, With Open-Label Extension

Study design: Treatment, Randomized, Placebo Control, Safety/Efficacy Study

Minimum age: 1 Month. Maximum age: 23 Months. Gender(s): Both.

Criteria:

Inclusion Criteria: 1-23 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

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For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm

Ending date: August 2006
Last updated: June 28, 2007