Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
4+ years
Phase:
PHASE3
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 o...
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," involvi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1996
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00236418
Start Date
December 1 1994
End Date
December 1 1996
Last Update
June 8 2011
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