An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Subject is a male or female aged ≥ 16 years

• Subject has Partial Onset Seizures that are classifiable according to the 1981 International League Against Epilepsy (ILAE) classification of Epileptic Seizures

• Subject weighs ≥ 40 kg

• Subject is currently taking Levetiracetam (LEV) as an adjunctive antiepileptic oral treatment with 1 to 3 other Antiepileptic Drugs (AEDs)

Exclusion Criteria:

• Subject has problems with venous accessibility

• Subject has participated in another clinical/pharmacological study during the last 4 weeks prior to the Screening Visit

• Subject is pregnant or lactating

• Subject has a history of suicide attempt(s) or presents with current depressive signs, current suicidal ideation, and/or behavior

• Subject has clinically significant Electrocardiogram (ECG) abnormalities according to the investigator