A Pilot Study of Topiramate in Childhood Absence Epilepsy

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210574
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Epilepsy, Absence
Drug: topiramate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Topiramate in Childhood Absence Epilepsy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of subjects who become seizure-free.

Secondary Outcome Measures:
  • 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.

Enrollment: 12
Study Start Date: March 2005
Study Completion Date: October 2006
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

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210574

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00210574     History of Changes
Other Study ID Numbers: CR002872
Study First Received: September 13, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
childhood absence epilepsy
epilepsy
seizures
absence seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on September 22, 2014