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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Children 12-16 years old

Group Type EXPERIMENTAL

Keppra XR

Intervention Type 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

Adults 18-55 years old

Group Type EXPERIMENTAL

Keppra XR

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Levetiracetam XR

Eligibility Criteria

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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