An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Japan Co. Ltd.
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• Subject is male or female and aged ≥ 16 years at Visit 1

• Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures

• Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1

• Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

• Subject has a history or presence of seizure types other than partial (IA, IB, IC)

• Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1

• Subject has a history or presence of known Pseudo-Seizures

• Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1

• Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol