A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsies, Partial; Epilepsy, Generalized; Seizures; Epilepsy, Tonic-Clonic; Epilepsy
Intervention: topiramate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
The purpose of this study is to compare the safety and effectiveness of two doses of
topiramate as monotherapy in the treatment of pediatric and adult patients with newly
diagnosed or recurrent epilepsy.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Group, Monotherapy Study to Compare the Safety and Efficacy of Two Doses of Topiramate in the Treatment of Newly Diagnosed or Recurrent Epilepsy
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to first seizure (partial onset or generalized tonic-clonic seizure) during the core double-blind phase (excluding taper).
Secondary outcome: Mean plasma topiramate levels for the high and low topiramate dosing groups; laboratory evaluations, vital signs, visual field testing results, and adverse events during trial
Detailed description:
Topiramate is approved for treating epilepsy in combination with other epilepsy drugs, but
not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy
characterized by partial-onset seizures. This is a randomized, double-blind, parallel-group,
multicenter study to compare the safety and effectiveness of two doses of topiramate as
monotherapy in pediatric and adult patients with newly diagnosed (within 3 months) or
recurrent epilepsy (partial-onset or primary generalized tonic-clonic). The study consists of
4 phases: Baseline (assessment of seizure frequency and other eligibility), Open-Treatment
(all patients receive 25 milligrams[mg]/day of topiramate for 7 days), Core Double-Blind
Phase (patients are randomized to receive either their assigned dose of topiramate of
50mg/day or 400mg/day, or maximum tolerated dose, and then remain, if possible, on that dose
for the duration of the double-blind phase; they continue to receive the medication until
they experience the first seizure or until 6 months after the last patient is enrolled), and
Long-Term Extension Phase (patients continue to receive the medication at maximum tolerated
dose, which may be adjusted according to individual tolerability and effectiveness, until
either the patient withdraws or the sponsor terminates the study). The study hypothesis is
that topiramate will be effective in the treatment of newly diagnosed or recurrent epilepsy
in dose-dependent manner.
Topiramate tablets (25 milligrams[mg]) daily by mouth in once-daily regimen during the 7-day
Open-Treatment Phase; topiramate twice daily for total of 50mg/day or 400mg/day during the
Double-Blind Phase.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Weigh >=25 kilograms
- Diagnosis of epilepsy within 3 months prior to study entry or recurrence of epilepsy
while off of anit-epileptic drugs
- No more than two documented seizures during the three-month retrospective baseline
phase
- May have experienced seizures prior to the three-month, retrospective baseline phase
- Patients with partial-onset seizures, with or without a secondarily generalized
component, and generalized seizures, including tonic-clonic (grand mal), tonic,
clonic, juvenile myoclonic epilepsy (impulsive petit mal) and myoclonic epilepsy
- Receiving either no other concomitant anti-epileptic drug (AED) or be on one standard
AED
Exclusion Criteria:
- Patients who do not have epilepsy
- Patients with absence (petit mal) or atypical absence seizures, epilepsia paritlis
continua, cluster pattern or serial seizures
- Patients with progressive neurological or degenerative disorder
- Patients with significant history of unstable medical diseases
- Patients with a drug allergy or hypersensitivity to carbonic anhydrase inhibitors or
sulfa drugs
- Patients with history of alcohol or drug abuse within past one year
- Patients with a history of suicide attempt within past one year
Locations and Contacts
Additional Information
A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
Starting date: July 1999
Ending date: September 2003
Last updated: May 11, 2007
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