Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
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|ClinicalTrials.gov Identifier: NCT00160550|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 26, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Generalized Convulsive Epilepsy||Drug: Levetiracetam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Pediatric Subjects (4-65 Years) Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic (PGTC) Seizures.|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
- The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).
- Reduction during the Treatment Period in PGTC seizure frequency
- Percentage reduction during the Treatment Period in seizure days
- Responder rates in PGTC seizure frequency, and in seizure days of all types.
- The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations
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|Ages Eligible for Study:||4 Years to 65 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160550
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|
|Other Study ID Numbers:||
|First Posted:||September 12, 2005 Key Record Dates|
|Last Update Posted:||November 26, 2013|
|Last Verified:||September 2009|
Idiopathic Generalized Epilepsy, tonic-clonic seizures
Central Nervous System Diseases
Nervous System Diseases