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

March 25, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
      • Rio Negro, Argentina
      • Santa Fe, Argentina
  • Australia
      • Heidelberg West, Australia
      • Melbourne, Australia
      • Subiaco, Australia
  • Belgium
      • Antwerpen, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Pulderbos, Belgium
  • Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Chile
      • Chile, Chile
      • Santiago, Chile
  • Finland
      • Helsinki, Finland
      • Tampere, Finland
  • France
      • Bordeaux Cedex, France
      • Lille, France
      • Tours Cedex 9, France
  • Hungary
      • Budapest, Hungary
  • India
      • Chennai, India
      • Hyderabad Gpo, India
      • Kochi Ho, India
      • Mumbai, India
      • New Delhi, India
      • Pune, India
  • Israel
      • Petah Tikva, Israel
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Mexico
      • Monterrey, Mexico
      • San Luis Potosi, Mexico
  • Netherlands
      • Heeze, Netherlands
  • New Zealand
      • Wellington, New Zealand
  • Norway
      • Bergen, Norway
  • Poland
      • Gdansk, Poland
      • Warszawa N/A, Poland
  • Russian Federation
      • Ekaterinburg Siberia, Russian Federation
      • Moscow, Russian Federation
      • Omsk Siberia, Russian Federation
      • Samara, Russian Federation
  • South Africa
      • Cape Town Wc, South Africa
  • Spain
      • Madrid, Spain
  • Taiwan
      • Taipei, Taiwan
  • Thailand
      • Bangkok, Thailand
      • Chiangmai, Thailand
  • Ukraine
      • Donetsk, Ukraine
      • Kiev, Ukraine
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • California
      • Los Angeles, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Delaware
      • Wilmington, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Loxahatchee, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Park Ridge, Illinois, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Dearborn, Michigan, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
      • Springfield, Missouri, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Newark, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • Mineola, New York, United States
      • Rochester, New York, United States
      • Stony Brook, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Durham, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Danville, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Texas
      • Fort Worth, Texas, United States
      • Plano, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 003
topiramate 25 mg/kg/day
Drug: topiramate
15 mg/kg/day
Drug: topiramate
5 mg/kg/day
Drug: topiramate
25 mg/kg/day
EXPERIMENTAL: 002
topiramate 15 mg/kg/day
Drug: topiramate
15 mg/kg/day
Drug: topiramate
5 mg/kg/day
Drug: topiramate
25 mg/kg/day
EXPERIMENTAL: 001
topiramate 5 mg/kg/day
Drug: topiramate
15 mg/kg/day
Drug: topiramate
5 mg/kg/day
Drug: topiramate
25 mg/kg/day
EXPERIMENTAL: 004
placebo placebo
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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
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
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.
Time Frame: Baseline to endpoint of double blind phase
Baseline to endpoint of double blind phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

June 10, 2005

First Submitted That Met QC Criteria

June 10, 2005

First Posted (ESTIMATE)

June 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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