Clinical trial NCT01407523: An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures
Official title: An Open-label, Multicenter Study to Evaluate the Safety of Adjunctive Treatment With Intravenous Levetiracetam (L059 IV) in Epilepsy Patients Aged ≥ 16 Years With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Partial Onset Seizures
Keywords: Levetiracetam
Infusion
Epilepsy
Partial Onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-02
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Levetiracetam oral dose.


Eligibility 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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
timeFrame: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)
measure: Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
timeFrame: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)
Secondary outcomes:
measure: Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
timeFrame: Day 1
measure: Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
timeFrame: Day 4
measure: Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
timeFrame: Day 1
measure: Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
timeFrame: Day 4
measure: Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period
timeFrame: During the Evaluation Period (Day 1 to Day 4)
Other outcomes:
Locations:
city: Niigata-city
country: Japan
facility: 1
state: Niigata
city: Shizuoka-city
country: Japan
facility: 2
state: Shizuoka
city: Kodaira-city
country: Japan
facility: 3
state: Tokyo
city: Yamagata-city, Yamagata
country: Japan
facility: 4
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: