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

Tracking Information

First Received Date ^ICMJE

June 10, 2005

Last Updated Date

December 4, 2008

Start Date ^ICMJE

May 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ 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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00113815 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: Baseline to endpoint of double blind phase ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 post-treatment (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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Epilepsy
Seizures
Partial Seizure Disorder

Intervention ^ICMJE

Drug: topiramate
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

149

Completion Date

November 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 24 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00113815

Responsible Party

VP J&J PRD, Compound Development Team Leader, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study ID Numbers ^ICMJE

CR002233

Study Sponsor ^ICMJE

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Information Provided By

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP