A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.

Condition	Intervention	Phase
Generalized Convulsive Epilepsy	Drug: Levetiracetam	Phase III

Further Study Details: 

Primary Outcomes: Responder rate in myoclonic (type IIB) seizures days over 16 weeks
Secondary Outcomes: Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration
Expected Total Enrollment:  116

Ages Eligible for Study:  12 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included.
• Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period.
• Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period.
• Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1.
• Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1.
• Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1.

Exclusion Criteria:

• Previous exposure to levetiracetam.
• History of partial seizures.
• History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1.
• Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet.
• Subject taking any drug (except the concomitant AEDs) with possible CNS effects.

Study chairs or principal investigators

Françoise Tonner, MD,  Study Director,  UCB Pharma, Inc.   

Study ID Numbers:  N166
Last Updated:  September 9, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150774
Health Authority: Austria: Federal Ministry for Health and Women; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Ireland: Irish Medicines Board; Italy: Ministry of Health; Mexico: National Institute of Public Health, Health Secretariat; New Zealand: Food Safety Authority; Poland: Ministry of Health; Spain: Ministry of Health and Consumption; Switzerland: Swissmedic; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13