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

Primary Purpose

Epilepsy, Partial Onset Seizures

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Japan Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Infusion, Epilepsy, Partial Onset Seizures

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 1
  • 2
  • 3
  • 4

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.

Secondary Outcome Measures

Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.
Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.
Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg.
Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg.
Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Full Information

First Posted
July 29, 2011
Last Updated
January 30, 2013
Sponsor
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01407523
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Onset Seizures
Keywords
Levetiracetam, Infusion, Epilepsy, Partial Onset Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra®, E Keppra®
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
Description
An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
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)
Title
Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.
Time Frame
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 Outcome Measure Information:
Title
Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Description
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.
Time Frame
Day 1
Title
Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Description
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.
Time Frame
Day 4
Title
Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Description
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg.
Time Frame
Day 1
Title
Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Description
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg.
Time Frame
Day 4
Title
Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period
Description
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
During the Evaluation Period (Day 1 to Day 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
1
City
Niigata-city
State/Province
Niigata
Country
Japan
Facility Name
2
City
Shizuoka-city
State/Province
Shizuoka
Country
Japan
Facility Name
3
City
Kodaira-city
State/Province
Tokyo
Country
Japan
Facility Name
4
City
Yamagata-city, Yamagata
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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