An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures
NCT ID: NCT01407523
Last Updated: 2013-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2011-07-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levetiracetam
Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Levetiracetam
* Formulation: concentrate for solution for infusion
* Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
* Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
* Frequency: twice daily
Interventions
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Levetiracetam
* Formulation: concentrate for solution for infusion
* Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
* Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
* Frequency: twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
ALL
No
Sponsors
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UCB Japan Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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1
Niigata, Niigata, Japan
2
Shizuoka, Shizuoka, Japan
3
Kodaira, Tokyo, Japan
4
Yamagata-city, Yamagata, , Japan
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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N01378
Identifier Type: -
Identifier Source: org_study_id
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