Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00544050
First received: October 15, 2007
Last updated: November 14, 2013
Last verified: September 2009
  Purpose

The primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month to less than 4 years.


Condition Intervention Phase
Epilepsy
Drug: Levetiracetam
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.

Enrollment: 13
Study Start Date: September 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female between 1 month and less than 4 years
  • diagnosis of any type of epilepsy
  • at least 5 kg body weight
  • using no more than two antieplieptic drugs

Exclusion Criteria:

  • a treatable seizure etiology
  • epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease
  • history of status epilepticus during the 2 weeks prior to the Selection Visit
  • history of or the presence of pseudoseizures
  • epilepsy surgery within one year prior to the Selection Visit
  • on a ketogenic diet
  • taking felbamate at the Selection Visit
  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: NCT00544050

Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00544050     History of Changes
Other Study ID Numbers: N01052
Study First Received: October 15, 2007
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014