search
Back to results

A Pilot Study of Topiramate in Childhood Absence Epilepsy

Primary Purpose

Epilepsy, Absence

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
topiramate
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Absence focused on measuring childhood absence epilepsy, epilepsy, seizures, absence seizures

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho-McNeil Neurologics, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00210574
    Brief Title
    A Pilot Study of Topiramate in Childhood Absence Epilepsy
    Official Title
    A Pilot Study of Topiramate in Childhood Absence Epilepsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho-McNeil Neurologics, Inc.

    4. Oversight

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Absence
    Keywords
    childhood absence epilepsy, epilepsy, seizures, absence seizures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    Proportion of subjects who become seizure-free.
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=497&filename=CR002872_CSR.pdf
    Description
    A Pilot Study of Topiramate in Childhood Absence Epilepsy

    Learn more about this trial

    A Pilot Study of Topiramate in Childhood Absence Epilepsy

    We'll reach out to this number within 24 hrs