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

August 17, 2009
August 30, 2011
September 2009
March 2010   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: No ]

    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 [ 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. ] [ Designated as safety issue: No ]

    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 [ 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. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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.
Maximum Concentration (Cmax); Time of Cmax (tmax); Area Under Curve over a dosing interval (AUCT); Apparent Total Body Clearance (CL/F). Cmax and AUCT will also be normalized by dose, by kg body weight and by both. [ Time Frame: 6 PK sample from pre-dose to 10h after administration, at Day 4, 5, 6, or 7 of Keppra XR administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00961441 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Adverse Events (including seizure worsening) [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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

Other Name: Levetiracetam XR
  • Experimental: Children 12-16 years old
    Intervention: Drug: Keppra XR
  • Experimental: Adults 18-55 years old
    Intervention: Drug: Keppra XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a diagnosis of epilepsy on up to three concomitant anti-epileptic drugs.
  • Subjects on levetiracetam 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.
Both
12 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00961441
N01340
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP