Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
UCB |
---|---|
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00150735 |
A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.
Condition | Intervention | Phase |
---|---|---|
Generalized Epilepsy |
Drug: LEVETIRACETAM |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Double-Blind, Active Control, Parallel Assignment |
Official Title: | A Multicenter, Double-Blind, Randomized, Parallel Group, Positive-Controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-Clonic Seizures |
Estimated Enrollment: | 580 |
Study Start Date: | June 2002 |
Study Completion Date: | July 2005 |
Primary Completion Date: | July 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: | N01061 |
Study First Received: | September 6, 2005 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00150735 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; Sweden: Medical Products Agency; 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 Seizures Piracetam |
Central Nervous System Diseases Etiracetam Brain Diseases Epilepsy, Generalized |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |