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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 (1-24 Months of Age) With Refractory Partial-Onset Seizures

Conditions
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Partial Seizure Disorder, Epilepsy, Seizures

Intervention / Treatment
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* Drug: topiramate
* Drug: topiramate
* Drug: topiramate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 003<br>topiramate 25 mg/kg/day | Drug: topiramate<br>* 25 mg/kg/day<br>|
| Experimental: 002<br>topiramate 15 mg/kg/day | Drug: topiramate<br>* 15 mg/kg/day<br>|
| Experimental: 001<br>topiramate 5 mg/kg/day | Drug: topiramate<br>* 5 mg/kg/day<br>|
| Experimental: 004<br>placebo placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial seizure disorder, Topiramate, Epilepsy, Infants