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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00150787 |
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 |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Parallel Assignment |
Official Title: | A Multicenter, Double-Blind, Follow-up Trial Evaluating the Long-Term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial. |
Estimated Enrollment: | 250 |
Study Start Date: | July 2003 |
Study Completion Date: | November 2005 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | N01093 |
Study First Received: | September 6, 2005 |
Last Updated: | March 7, 2008 |
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 Medical 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 |
Monotherapy, epilepsy Levetiracetam Keppra |
Carbamazepine Epilepsy Piracetam Central Nervous System Diseases |
Etiracetam Epilepsy, Tonic-Clonic Brain Diseases Epilepsy, Generalized |
Nootropic Agents Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Protective Agents Neuroprotective Agents |
Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |