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

• ClinicalTrials.gov Identifier: NCT00961441
• Recruitment Status: Completed
• First Posted: August 19, 2009
• Results First Posted: May 25, 2011
• Last Update Posted: August 6, 2015
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Epilepsy	Drug: Keppra XR	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: September 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

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 BIOSCIENCES, Inc.

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB BIOSCIENCES, Inc.
• ClinicalTrials.gov Identifier: NCT00961441
• Other Study ID Numbers: N01340; 2014-004376-39 ( EudraCT Number )
• First Posted: August 19, 2009
• Results First Posted: May 25, 2011
• Last Update Posted: August 6, 2015
• Last Verified: July 2015

Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):

Levetiracetam; Epilepsy; Children; Adults

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Levetiracetam; Anticonvulsants; Nootropic Agents