Status:
COMPLETED
A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 epilep...
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00231556
Start Date
July 1 1999
End Date
September 1 2003
Last Update
June 8 2011
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