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Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
This study has been completed.
First Received: June 10, 2005   Last Updated: December 4, 2008   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00113815
  Purpose

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


Condition Intervention Phase
Epilepsy
Seizures
Partial Seizure Disorder
Drug: topiramate
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 149
Study Start Date: May 2005
Study Completion Date: November 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: topiramate
5 mg/kg/day
002: Experimental Drug: topiramate
15 mg/kg/day
003: Experimental Drug: topiramate
25 mg/kg/day
004: Experimental Drug: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113815

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( VP J&J PRD, Compound Development Team Leader )
Study ID Numbers: CR002233
Study First Received: June 10, 2005
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00113815     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Epilepsy
Infants
Topiramate
Partial seizure disorder

Additional relevant MeSH terms:
Epilepsies, Partial
Physiological Effects of Drugs
Seizures
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Anti-Obesity Agents
Signs and Symptoms
Epilepsy
Therapeutic Uses
Neurologic Manifestations
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 09, 2009