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Completed

NCT Number: NCT00961441

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keppra XR

Drug

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 names: Levetiracetam XR

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 19, 2009
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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