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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00175903 |
Open label, multicenter, international, randomized, parallel group, phase IIIb study comparing the efficacy and safety of levetiracetam to two standard antiepileptic drugs (CBZ and VPA) in patients with newly diagnosed epilepsy in a clinical practice setting.
Condition | Intervention | Phase |
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Epilepsy |
Drug: LEVETIRACETAM (UCB) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Therapeutic Confirmatory, Open-Label, Multi-Center, Randomized 2 Parallel Groups, Community-Based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy. |
Enrollment: | 1701 |
Study Start Date: | February 2005 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | SONJA BUYLE, MD | UCB |
Study ID Numbers: | N01175, EUDRACT NUMBER: 2004-001339-41 |
Study First Received: | September 9, 2005 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00175903 |
Health Authority: | Austria: Federal Ministry for Health and Women; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Ireland: Irish Medicines Board; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: FSI Scientific Center of Expertise of Medical Application; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Spain: Ministry of Health and Consumption; Sweden: Medical Products Agency; Switzerland: Swissmedic; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Hungary: National Institute of Pharmacy; Romania: State Institute for Drug Control |
NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, CARBAMAZEPINE, VALPROATE |
Carbamazepine Epilepsy Central Nervous System Diseases |
Etiracetam Brain Diseases Valproic Acid |
Nootropic Agents Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents |
Pharmacologic Actions Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses GABA Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents Anticonvulsants |