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

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy; Partial Onset Seizures

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01407523

N01378

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Levetiracetam

Experimental group

Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

Treatment:

Drug: Levetiracetam