Status:
COMPLETED
An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures
Lead Sponsor:
UCB Japan Co. Ltd.
Conditions:
Epilepsy
Partial Onset Seizures
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 Levetirace...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01407523
Start Date
July 1 2011
End Date
February 1 2012
Last Update
March 7 2013
Active Locations (4)
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1
1
Niigata, Niigata, Japan
2
2
Shizuoka, Shizuoka, Japan
3
3
Kodaira, Tokyo, Japan
4
4
Yamagata-city, Yamagata, Japan