Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00961441
First received: August 17, 2009
Last updated: August 30, 2011
Last verified: April 2011
Results First Received: March 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: Keppra XR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Intent-to-treat (ITT) population includes all enrolled patients who received at least one dose of study medication.Pharmacokinetic Per-Protocol (PK-PP) population is a subset of the ITT population, consisting of those patients who had no major protocol deviations affecting the pharmacokinetic parameters.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow and Baseline characteristics refer to the Intention-to-treat (ITT) population.

Reporting Groups
  Description
Keppra XR in Children (12-16 Years Old)

Drug: Keppra XR

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

Keppra XR in Adults (18-55 Years Old)

Drug: Keppra XR

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


Participant Flow:   Overall Study
    Keppra XR in Children (12-16 Years Old)     Keppra XR in Adults (18-55 Years Old)  
STARTED     12     13  
Pharmacokinetic (PK-PP) Population     12     10 [1]
COMPLETED     12     13  
NOT COMPLETED     0     0  
[1] Two subjects were excluded due to study medication noncompliance, one due to wrong dosing regimen.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Keppra XR in Children (12-16 Years Old)

Drug: Keppra XR

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

Keppra XR in Adults (18-55 Years Old)

Drug: Keppra XR

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

Total Total of all reporting groups

Baseline Measures
    Keppra XR in Children (12-16 Years Old)     Keppra XR in Adults (18-55 Years Old)     Total  
Number of Participants  
[units: participants]
  12     13     25  
Age  
[units: years]
Mean ± Standard Deviation
  14.88  ± 1.37     41.78  ± 9.21     28.87  ± 15.21  
Gender  
[units: participants]
     
Female     6     8     14  
Male     6     5     11  
Weight  
[units: kilogram¬†(kg)]
Mean ± Standard Deviation
  77.2  ± 24.1     82.5  ± 23.0     80.0  ± 23.2  
Height  
[units: centimeter¬†(cm)]
Mean ± Standard Deviation
  165.9  ± 8.8     169.3  ± 10.3     167.7  ± 9.6  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  27.62  ± 7.01     28.63  ± 7.14     28.14  ± 6.95  
Body Surface Area (BSA)  
[units: m^2]
Mean ± Standard Deviation
  1.87  ± 0.34     1.95  ± 0.32     1.91  ± 0.32  
Race  
[units: Participants]
     
Black     4     3     7  
Caucasian     8     9     17  
Other / mixed     0     1     1  



  Outcome Measures
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1.  Primary:   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   [ 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. ]

2.  Primary:   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   [ 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. ]

3.  Primary:   Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of 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. ]

4.  Primary:   Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of 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. ]

5.  Secondary:   Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days   [ Time Frame: From Starting Study Drug Treatment (Day 1) to up to 14 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00961441     History of Changes
Other Study ID Numbers: N01340
Study First Received: August 17, 2009
Results First Received: March 15, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration