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

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Keppra XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961441

2014-004376-39 (EudraCT Number)

N01340

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Children 12-16 years old

Experimental group

Treatment:

Drug: Keppra XR

Adults 18-55 years old

Experimental group

Treatment:

Drug: Keppra XR