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

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ClinicalTrials.gov Identifier: NCT00113815
Recruitment Status : Completed
First Posted : June 13, 2005
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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).

Condition or disease Intervention/treatment Phase
Partial Seizure Disorder Epilepsy Seizures Drug: topiramate Drug: placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2007


Arm Intervention/treatment
Experimental: 003
topiramate 25 mg/kg/day
Drug: topiramate
25 mg/kg/day
Experimental: 002
topiramate 15 mg/kg/day
Drug: topiramate
15 mg/kg/day
Experimental: 001
topiramate 5 mg/kg/day
Drug: topiramate
5 mg/kg/day
Experimental: 004
placebo placebo
Drug: placebo
placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113815


  Show 94 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00113815     History of Changes
Other Study ID Numbers: CR002233
First Posted: June 13, 2005    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

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

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