search
Back to results

A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

Primary Purpose

Epilepsy, Seizures

Status
Completed
Phase
Phase 3
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 Epilepsy, Seizures, Topiramate, Prophylaxis, Antiepileptic, Tonic-clonic seizures, Grand mal seizures

Eligibility Criteria

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

Inclusion Criteria: Body weight >25 kilograms (55 pounds) diagnosis of primary generalized epilepsy must have primary generalized tonic-clonic (PGTC) seizures treated with 1 or 2 antiepileptic drugs must have three PGTC seizures during baseline period, with at least 1 during each 28-day period of baseline females must not have had their first menstrual period or be postmenopausal, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate birth control measures, and have a negative pregnancy test before study entry. Exclusion Criteria: Patients who do not have epilepsy, such as those with a treatable cause of seizure (for example, active infection or cancer) patients with progressive disorders (for example, active infection, cancer or metabolic disturbance) patients diagnosed with Lennox-Gastaut syndrome history of seizures occurring in only cluster patterns (numerous seizures occurring over a short period of time [<30 minutes]) documented history (previous 3 months) of generalized tonic-clonic status epilepticus (status epilepticus is a prolonged seizure or seizures repeated frequently over 20 to 30 minutes so that recovery between episodes does not occur) while receiving appropriate antiepileptic medication.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percent reduction from baseline in primary generalized tonic-clonic seizure rates and percent responders (>=50% reduction in PGTC seizure rate from baseline), during the double-blind phase. Subjects' global evaluation of improvement in seizure severity.

    Secondary Outcome Measures

    Percent reduction from baseline of all seizure types and percent of treatment responders in all seizure types, during the double-blind phase. 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
    NCT00236418
    Brief Title
    A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures
    Official Title
    Topiramate Clinical Trial in Primary Generalized Tonic-Clonic Seizures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1996 (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 evaluate the efficacy and safety of topiramate as an add-on therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic seizures, who are taking 1 or 2 standard antiepileptic drugs.
    Detailed Description
    Epilepsy is a disease characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," involving all or most of the brain at the same time, or "partial onset," starting in one area of the brain. Generalized tonic-clonic seizures are also referred to as grand mal seizures and are common in people with generalized epilepsy in which the cause is not known. In a tonic-clonic seizure, the person loses consciousness, the body stiffens (tonic phase), and then the individual falls to the ground. This is followed by jerking movements in which the muscles contract and relax quickly (clonic phase). After a minute or two, the jerking movements usually stop, and the person regains consciousness. Antiepileptic medications, such as topiramate, are selected based on a patient's seizure type. 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, placebo-controlled study to evaluate the effectiveness and safety of topiramate as an add-on therapy in patients with Primary Generalized Tonic-Clonic (PGTC) seizures. The study is in two phases: baseline (8 weeks) and double-blind treatment (20 weeks). Patients are given diaries to record information about their seizures during the phases of the study. During the baseline phase, the patient continues to receive a constant dosage of one or two antiepileptic drugs they have been taking. In the double-blind phase, patients are randomly assigned to either topiramate or placebo. The double-blind phase is divided into two periods: titration, in which the topiramate dose is gradually increased (8 weeks) (patient's antiepileptic medication continues; this dose remains the same) and stabilization (12 weeks). The dose of both topiramate and the patient's antiepileptic drug remain constant during the stabilization period. Based on the investigator's judgment, patients completing the double-blind treatment could enter a long-term extension phase of the study to continue treatment. The primary assessment of effectiveness is the percent reduction in primary generalized tonic-clonic seizure rates from baseline to the double-blind phase. Safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology, biochemistry, and urinalysis), measurements of vital signs and body weight, physical examination and electrocardiogram (ECG) findings, plasma levels of topiramate and other study antiepileptic drugs, and neurological examinations. The study hypothesis is that topiramate as an add-on is superior to placebo in reducing the seizure rate from baseline to the double-blind phase of the study. Topiramate (25 mg or 100 mg tablets) or placebo, taken by mouth, starting at a dose of 25 or 50mg/day, gradually increasing to a maximum daily dose of 175 mg to 400 mg (based on body weight) or to a maximum tolerated dose (whichever dose is less). Maximum dosage continues for 12 weeks.

    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, Tonic-clonic seizures, Grand mal seizures

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    Percent reduction from baseline in primary generalized tonic-clonic seizure rates and percent responders (>=50% reduction in PGTC seizure rate from baseline), during the double-blind phase. Subjects' global evaluation of improvement in seizure severity.
    Secondary Outcome Measure Information:
    Title
    Percent reduction from baseline of all seizure types and percent of treatment responders in all seizure types, during the double-blind phase. Safety evaluations conducted throughout the study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Body weight >25 kilograms (55 pounds) diagnosis of primary generalized epilepsy must have primary generalized tonic-clonic (PGTC) seizures treated with 1 or 2 antiepileptic drugs must have three PGTC seizures during baseline period, with at least 1 during each 28-day period of baseline females must not have had their first menstrual period or be postmenopausal, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate birth control measures, and have a negative pregnancy test before study entry. Exclusion Criteria: Patients who do not have epilepsy, such as those with a treatable cause of seizure (for example, active infection or cancer) patients with progressive disorders (for example, active infection, cancer or metabolic disturbance) patients diagnosed with Lennox-Gastaut syndrome history of seizures occurring in only cluster patterns (numerous seizures occurring over a short period of time [<30 minutes]) documented history (previous 3 months) of generalized tonic-clonic status epilepticus (status epilepticus is a prolonged seizure or seizures repeated frequently over 20 to 30 minutes so that recovery between episodes does not occur) while receiving appropriate antiepileptic medication.
    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
    10768306
    Citation
    Montouris GD, Biton V, Rosenfeld WE. Nonfocal generalized tonic-clonic seizures: response during long-term topiramate treatment. Topiramate YTC/YTCE Study Group. Epilepsia. 2000;41(S1):77-81. doi: 10.1111/j.1528-1157.2000.tb02177.x.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=669&filename=CR005830_CSR.pdf
    Description
    A study of the efficacy and safety of topiramate in patients with primary generalized tonic-clonic seizures

    Learn more about this trial

    A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

    We'll reach out to this number within 24 hrs