Back to resultsStudy Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Keppra XR
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Epilepsy, Children, Adults
Eligibility Criteria
Inclusion Criteria:
- Subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs
- Subjects on levetiracetam immediate release (IR) can be enrolled if on a stable dose for 7 days
Exclusion Criteria:
- Subjects with a history of status epilepticus within 3 months of Visit 1
- Subject has difficult venous accessibility
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Children 12-16 years old
Adults 18-55 years old
Arm Description
Outcomes
Primary Outcome Measures
Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration
The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.
Cmax normalized by 1000 mg dose was calculated as:
Cmax/(mg dose taken/ 1000 mg Keppra XR).
Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:
Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).
Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration.
Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration
AUCtau normalized by 1000 mg dose was calculated as:
AUCtau/(mg dose taken/ 1000 mg Keppra XR).
AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:
AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).
6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau.
Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration
The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration
The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Secondary Outcome Measures
Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 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. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00961441
Brief Title
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
Official Title
An Open-Label, Multicenter, Parallel-Group, Two-Arm Study Comparing the Pharmacokinetics of Keppra XR in Children (Aged 12 - 16 Years Old) With Epilepsy and in Adults (Aged 18 - 55 Years Old) With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Levetiracetam, Epilepsy, Children, Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children 12-16 years old
Arm Type
Experimental
Arm Title
Adults 18-55 years old
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Keppra XR
Other Intervention Name(s)
Levetiracetam XR
Intervention Description
Keppra XR 500 mg tablets and Keppra XR 750 mg tablets
Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days
Primary Outcome Measure Information:
Title
Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration
Description
The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.
Cmax normalized by 1000 mg dose was calculated as:
Cmax/(mg dose taken/ 1000 mg Keppra XR).
Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:
Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).
Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration.
Time Frame
6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Title
Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration
Description
AUCtau normalized by 1000 mg dose was calculated as:
AUCtau/(mg dose taken/ 1000 mg Keppra XR).
AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:
AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).
6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau.
Time Frame
6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Title
Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration
Description
The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Time Frame
6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Title
Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration
Description
The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Time Frame
6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.
Secondary Outcome Measure Information:
Title
Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 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. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.
Time Frame
From Starting Study Drug Treatment (Day 1) to up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs
Subjects on levetiracetam immediate release (IR) can be enrolled if on a stable dose for 7 days
Exclusion Criteria:
Subjects with a history of status epilepticus within 3 months of Visit 1
Subject has difficult venous accessibility
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:
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Fairfield
State/Province
Connecticut
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Dallas
State/Province
Texas
Country
United States
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
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
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