search
Back to results

A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy

Primary Purpose

Epilepsy, Seizures

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Topiramate; Carbamazepine; Valproate
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 focused on measuring Epilepsy, Seizures, Topiramate, Prophylaxis, Antiepileptic

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Body weight of at least 30 kilograms New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry Exclusion Criteria: Patients who do not have epilepsy Have progressive or degenerative disorders (for example, certain hereditary conditions) Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases) Have mental retardation or other condition that could make interpretation of the study results difficult alcohol or drug abuse within the previous year

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to first seizure from Day 15 of the study

    Secondary Outcome Measures

    Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    June 6, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00236717
    Brief Title
    A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
    Official Title
    TOPAMAX (Topiramate) Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy (RWJ-17021-000); Phase IIIB
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2000 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.
    Detailed Description
    Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate (100 or 200mg per day) compared with standard antiepileptic drugs (carbamazepine or valproate) in patients with newly diagnosed epilepsy. The study is composed of three phases: baseline (up to 7 days), double-blind treatment, and a blinded extension. The double-blind phase is divided into two periods: titration, in which the dose of drug is gradually increased (approximately 35 days), and stabilization (of variable duration, with regular scheduled visits up to 92 days and then every 3 months thereafter). The dose of study drug remains constant during the stabilization period. In the blinded extension, patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion (patient unaware of identity of the drug). This phase continues until the patient leaves the study or the data base for the double blind phase is finalized. The primary assessment of effectiveness is the time to first seizure from Day 15 of the study. Safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology and biochemistry), measurements of vital signs and body weight, and physical examination findings. The study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated. Oral topiramate (25milligram [mg] or 50mg capsules or tablets),starting at 25mg/day (Week 1),increasing to 100mg or 200mg/day (Week 5).Increasing carbamazepine to 600mg/day or valproate to 1250mg/day (Week 5).Maximum dosages continue for a variable time and then taper over 4 weeks to starting dose.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Seizures
    Keywords
    Epilepsy, Seizures, Topiramate, Prophylaxis, Antiepileptic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    865 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Topiramate; Carbamazepine; Valproate
    Primary Outcome Measure Information:
    Title
    Time to first seizure from Day 15 of the study
    Secondary Outcome Measure Information:
    Title
    Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Body weight of at least 30 kilograms New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry Exclusion Criteria: Patients who do not have epilepsy Have progressive or degenerative disorders (for example, certain hereditary conditions) Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases) Have mental retardation or other condition that could make interpretation of the study results difficult alcohol or drug abuse within the previous year
    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

    Citations:
    PubMed Identifier
    15072107
    Citation
    Wheless JW, Neto W, Wang S; EPMN-105 Study Group. Topiramate, carbamazepine, and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. J Child Neurol. 2004 Feb;19(2):135-41. doi: 10.1177/08830738040190020901.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=646&filename=CR005461_CSR.pdf
    Description
    A study of the effectiveness and safety of topiramate compared with a standard single medicine therapy in patients newly diagnosed with epilepsy

    Learn more about this trial

    A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy

    We'll reach out to this number within 24 hrs