Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures

Generalized Convulsive Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160550
• Other study ID #: N01057
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: November 25, 2013
• Start date: September 2001
• Est. completion date: June 2005

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: National Institute of Public Health, Health SecretariatRussia: Pharmacological Committee, Ministry of HealthCanada: Health CanadaPoland: Ministry of HealthEstonia: The State Agency of MedicineUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Food Safety Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Gender: Both
• Age group: 4 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Generalized Convulsive Epilepsy

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (2)

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. Epub 2007 Jul 11. — View Citation

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).
Secondary	Reduction during the Treatment Period in PGTC seizure frequency
Secondary	Percentage reduction during the Treatment Period in seizure days
Secondary	Responder rates in PGTC seizure frequency, and in seizure days of all types.
Secondary	The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations

External Links

•   Clinical Study Summary on UCB.com