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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00150774 |
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 |
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Generalized Convulsive Epilepsy |
Drug: Levetiracetam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Levetiracetam (LEV) (Oral Tablets of 500 mg b.i.d.) at a Dose of 3000 mg/Day as Adjunctive Treatment in Adolescents (≥ 12 Years) and Adults (≤ 65 Years) Suffering From Idiopathic Generalized Epilepsy With Myoclonic Seizures. |
Estimated Enrollment: | 116 |
Study Start Date: | November 2001 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | N166 |
Study First Received: | September 6, 2005 |
Last Updated: | March 7, 2008 |
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 |
Idiopathic Generalized Epilepsy, Myoclonic seizures Keppra - Levetiracetam |
Myoclonus Myoclonus epilepsy Seizures Central Nervous System Diseases Brain Diseases Dyskinesias Epilepsies, Myoclonic |
Signs and Symptoms Epilepsy Neurologic Manifestations Piracetam Etiracetam Epilepsy, Generalized |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |