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| Sponsor: | UCB, Inc. |
|---|---|
| Information provided by: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00150774 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00150774 History of Changes |
| Other Study ID Numbers: | N166 |
| Study First Received: | September 6, 2005 |
| Last Updated: | February 22, 2010 |
| 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 |
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Idiopathic Generalized Epilepsy, Myoclonic seizures Keppra - Levetiracetam |
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Epilepsy Epilepsy, Generalized Epilepsies, Myoclonic Myoclonus Brain Diseases Central Nervous System Diseases Nervous System Diseases Dyskinesias Neurologic Manifestations Signs and Symptoms |
Etiracetam Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |