Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
12-30 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of topiramate as add-on therapy in the treatment of epilepsy patients with Lennox-Gastaut syndrome, a severe form of epilepsy in w...
Detailed Description
Lennox-Gastaut syndrome is a severe form of epilepsy that usually develops in children 4 years of age and younger. It is characterized by several seizure types and developmental delay. Tonic seizures,...
Eligibility Criteria
Inclusion
- Body weight of at least 25 pounds
- diagnosis of Lennox-Gastaut syndrome and an electroencephalogram (EEG) with an abnormal pulsation pattern
- atypical absence seizures and drop attacks (i.e., tonic-atonic seizures) among other seizure types that could include tonic-clonic, myoclonic, and minor-motor
- at least 60 seizures during the month before baseline
- must be maintained on 1 or 2 antiepileptic drugs
- females must not have had their first menstrual period, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate contraceptive measures, and have a negative pregnancy test before study entry.
Exclusion
- Patients whose seizures are due to a progressive disease (for example, active infection, cancer or metabolic disturbance)
- have a significant recent history (within 2 years) of medical diseases (respiratory, heart, gastrointestinal, blood diseases, rheumatic fever or cancer)
- history of alcohol or drug abuse.
Key Trial Info
Start Date :
August 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2001
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00236756
Start Date
August 1 1993
End Date
February 1 2001
Last Update
June 3 2011
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