Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

Phase 3

Completed

• Conditions: Partial Seizure Disorder; Epilepsy; Seizures
• Interventions: Drug: topiramate; Drug: placebo

• Registration Number: NCT00113815
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

Detailed Description

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-10
• Study First Submitted QC: 2005-06-10
• Study First Posted: 2005-06-13
• Primary Completion: 2007-06
• Study Completion: 2007-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
002	topiramate	topiramate 15 mg/kg/day
001	topiramate	topiramate 5 mg/kg/day
004	placebo	placebo placebo
003	topiramate	topiramate 25 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader	Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader

Secondary Outcome Measures

Name	Time	Method
Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.	Baseline to endpoint of double blind phase