Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Generalized Convulsive Epilepsy
Eligibility:
All Genders
4-65 years
Phase:
PHASE3
Brief Summary
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures...
Eligibility Criteria
Inclusion
- Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
- Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
- Absence of brain lesion documented on a CT scan or MRI.
- An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
- Male/female subject, \>=4 or \<=65 years of age at Visit 1.
- Subject on a stable dose of one or two AEDs during baseline.
Exclusion
- Previous exposure to levetiracetam.
- History of partial seizures.
- History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00160550
Start Date
September 1 2001
End Date
June 1 2005
Last Update
November 26 2013
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