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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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

UCB Pharma

Study Description

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 in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.

Condition or disease	Intervention/treatment	Phase
Generalized Convulsive Epilepsy	Drug: Levetiracetam	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	154 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators

UCB Pharma

Investigators

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Study Director:	UCB Clinical Trial Call Center	UCB Pharma

More Information

Publications of Results:

Berkovic SF, Knowlton RC, Leroy RF, Schiemann J, Falter U; Levetiracetam N01057 Study Group. Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy. Neurology. 2007 Oct 30;69(18):1751-60. doi: 10.1212/01.wnl.0000268699.34614.d3. Epub 2007 Jul 11.

Rosenfeld WE, Benbadis S, Edrich P, Tassinari CA, Hirsch E. Levetiracetam as add-on therapy for idiopathic generalized epilepsy syndromes with onset during adolescence: analysis of two randomized, double-blind, placebo-controlled studies. Epilepsy Res. 2009 Jul;85(1):72-80. doi: 10.1016/j.eplepsyres.2009.02.016. Epub 2009 Mar 26.

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ClinicalTrials.gov Identifier:	NCT00160550
Other Study ID Numbers:	N01057
First Posted:	September 12, 2005 Key Record Dates
Last Update Posted:	November 26, 2013
Last Verified:	September 2009

Keywords provided by UCB Pharma:


Idiopathic Generalized Epilepsy, tonic-clonic seizures Levetiracetam, Keppra

Additional relevant MeSH terms:

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Epilepsy Seizures Epilepsy, Generalized Brain Diseases Central Nervous System Diseases	Nervous System Diseases Neurologic Manifestations Levetiracetam Anticonvulsants Nootropic Agents

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