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A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.

Primary Purpose

Epilepsy, Epilepsies, Partial, Seizures

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 focused on measuring topiramate, epilepsy, partial epilepsies, partial epilepsy, seizures, epileptic seizures, partial seizure disorder, brain diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: History of simple or complex partial epilepsy that has been documented or witnessed an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks and no seizure-free interval longer than 3 weeks good physical health. Exclusion Criteria: Patients having solely generalized seizures or lacking documentation of partial epilepsy patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy generalized seizures, which are defined by the EEG wave pattern seizures that lack an abnormal pulsation pattern on EEG female patients who are pregnant or nursing, or those not using adequate birth control if capable of having children

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percent reduction in the average monthly seizure rate from baseline to end of treatment

    Secondary Outcome Measures

    Percent of patients responding to treatment. Percent reduction in generalized seizures. Patient's and investigator's global assessments at end of study and incidence of adverse events throughout study.

    Full Information

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

    Unique Protocol Identification Number
    NCT00236873
    Brief Title
    A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.
    Official Title
    Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1989 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 1993 (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 the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic drugs.
    Detailed Description
    Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain. Antiepilepsy medications, such as topiramate, are selected based on seizure type. This is a double-blind, placebo-controlled study to evaluate topiramate efficacy and safety as add-on therapy in partial epilepsy patients. This study includes a baseline phase and a treatment phase. During the baseline phase (8 weeks duration), patients receive one or two standard antiepileptic drugs (AEDs), such as phenytoin, carbamazepine, phenobarbital, primidone, or valproic acid. Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase. Patients then receive topiramate or placebo at a dosage of 100 milligrams once daily, increasing gradually over 3 weeks to 2 tablets twice daily (400 mg/day) or maximum tolerated dose, and maintained on that dose for 8 weeks (11 weeks is the total duration of the double-blind phase), while continuing on their standard AED regimen. Assessments of effectiveness include the percent reduction in the average monthly seizure rate, percent of patients responding to treatment (having equal to or greater than 50% reduction in seizure rate), and, the patient's and investigator's global assessments of medication at end of study. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse, temperature) weekly during the treatment phase. The study hypothesis is that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency, compared with placebo, in patients with refractory partial epilepsy: that is, in patients who continue to have seizures despite treatment with a first-line AEDs. In addition, it is hypothesized that topiramate is well tolerated. Topiramate, 100 milligrams (mg) oral tablets (or placebo). Dosage begins at 100 mg once daily and increases gradually over 3 weeks to 2 tablets twice daily (400 mg/day, maximum) or maximum tolerated dose for an additional 8 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Epilepsies, Partial, Seizures
    Keywords
    topiramate, epilepsy, partial epilepsies, partial epilepsy, seizures, epileptic seizures, partial seizure disorder, brain diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    Percent reduction in the average monthly seizure rate from baseline to end of treatment
    Secondary Outcome Measure Information:
    Title
    Percent of patients responding to treatment. Percent reduction in generalized seizures. Patient's and investigator's global assessments at end of study and incidence of adverse events throughout study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of simple or complex partial epilepsy that has been documented or witnessed an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks and no seizure-free interval longer than 3 weeks good physical health. Exclusion Criteria: Patients having solely generalized seizures or lacking documentation of partial epilepsy patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy generalized seizures, which are defined by the EEG wave pattern seizures that lack an abnormal pulsation pattern on EEG female patients who are pregnant or nursing, or those not using adequate birth control if capable of having children
    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
    8956919
    Citation
    Sharief M, Viteri C, Ben-Menachem E, Weber M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res. 1996 Nov;25(3):217-24. doi: 10.1016/s0920-1211(96)00029-0.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=665&filename=CR005563_CSR.pdf
    Description
    A study of the efficacy and safety of topiramate in the treatment of patients with epilepsy

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    A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.

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