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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113815

Enrollment

118

Registered

2005-06-13

Start date

2005-05-31

Completion date

2007-11-30

Last updated

2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Partial Seizure Disorder, Seizures

Keywords

Partial seizure disorder, Topiramate, Epilepsy, Infants

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.

Interventions

DRUGtopiramate

15 mg/kg/day

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 24 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Argentina, Australia, Belgium, Canada, Chile, Finland, France, Hungary, India, Israel, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026