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 Pharma
ClinicalTrials.gov Identifier:
NCT00961441
First received: August 17, 2009
Last updated: August 30, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Keppra XR
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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 [ 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 25
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Other Name: Levetiracetam XR
Experimental: 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

Other Name: Levetiracetam XR

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961441

Locations
United States, Alabama
Mobile, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, Connecticut
Fairfield, Connecticut, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
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

Keywords provided by UCB Pharma:
Levetiracetam
Epilepsy
Children
Adults

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on October 16, 2014