Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy
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|ClinicalTrials.gov Identifier: NCT00150735|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Generalized Epilepsy||Drug: LEVETIRACETAM||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||580 participants|
|Intervention Model:||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|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
- To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.
- Proportion of subjects with one year seizure freedom; time to first seizure; safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150735
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|