A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

Condition	Intervention	Phase
Epilepsy, Tonic-Clonic	Drug: LEVETIRACETAM	Phase III

Further Study Details: 

Primary Outcomes: Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
Expected Total Enrollment:  250

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects with a confirmed diagnosis of epilepsy.
• Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
• Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion Criteria:

• Need for an additional AED.

Study chairs or principal investigators

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

Study ID Numbers:  N01093
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150787
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; Spain: Ministry of Health and Consumption; Netherlands: Medicines Evaluation Board (MEB); Germany: Federal Institute for Drugs and Medicinal Devices; Hungary: National Institute of Pharmacy; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Finland: National Agency for Medicines; South Africa: Medicines Control Council; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Poland: Ministry of Health; Sweden: Medical Products Agency
ClinicalTrials.gov processed this record on 2005-09-13