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A Pilot Study of Topiramate in Childhood Absence Epilepsy

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ClinicalTrials.gov Identifier: NCT00210574
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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Brief Summary:
Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this condition. The present study is designed to provide further evidence of the potential effectiveness of topiramate for childhood absence epilepsy, as well as preliminary information about a potential target dose for future study.

Condition or disease Intervention/treatment Phase
Epilepsy, Absence Drug: topiramate Phase 2

Detailed Description:
Childhood Absence Epilepsy (CAE) affects 2-11% of all children with epilepsy. CAE occurs most frequently in children between the ages of 4 and 10 years. Children with CAE have brief seizures (usually several seconds in duration) that typically involve staring and loss of awareness; twitching movement of the face or other areas of the body may also occur. Absence seizures are provoked by deep breathing for several minutes ("hyperventilation"). Topiramate is known to be effective in several types of seizures in children. Preliminary data from studies on other types of epilepsy, as well as case reports, suggest that it may also be effective in the type of seizures that occur in CAE. The objective of the study is to gather additional preliminary data on the effectiveness and the potential target dose of topiramate in CAE. Because CAE is not expected to resolve spontaneously in the age group being studied, no control group will be included. Patients in the study will receive increasing doses of topiramate, with the starting dose and dose increases at weekly intervals. The starting dose and dosage increases will be based on the child's weight. At each visit, hyperventilation will be used to determine if seizures can be provoked. If seizures occur, the dose will be further increased to the maximum dose for the study. If seizures do not occur with hyperventilation, an electroencephalogram (EEG) will be performed to confirm that the seizures are not occurring. If the EEG confirms that no seizures are occurring, topiramate dose will be maintained for 12 weeks. Topiramate will be given in the form of "sprinkles" contained within capsules that may be opened and the drug sprinkled onto food. Starting dose will depend on the child's weight, then increased to a maximum dose: 9 milligrams/kilogram/day or 400 milligrams/day, whichever is less for up to 162 days
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Topiramate in Childhood Absence Epilepsy
Study Start Date : March 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Topiramate

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who become seizure-free.

Secondary Outcome Measures :
  1. Change in number of seizures per hour; change in duration of EEG spike wave discharges per hour; relationship between the lack of seizures and the blood level of topiramate.

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight of at least 15 kg (33 pounds)
  • confirmed diagnosis of childhood absence epilepsy
  • no other serious health problems or neurologic problems
  • have not taken anti-epilepsy drugs other than ethosuximide, lamotrigine, or valproate
  • able to take oral medication in a sprinkle capsule formulation
  • girls must not have gotten their first menstrual period.

Exclusion Criteria:

  • No seizures that are caused by something other than childhood absence epilepsy
  • not taken topiramate, primidone, zonisamide, or phenobarbital in the past
  • had to stop taking an anti-epilepsy drug (ethosuximide, lamotrigine, or valproate) because it was not effective in treating childhood absence epilepsy
  • no presence of abnormal brain waves on electroencephalogram
  • no presence of mental retardation, no autism, or severe developmental disorder.
Contacts and Locations
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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): NCT00210574


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho-McNeil Neurologics, Inc.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00210574    
Other Study ID Numbers: CR002872
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: April 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
childhood absence epilepsy
epilepsy
seizures
absence seizures
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
 Epileptic Syndromes
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs