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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:
ClinicalTrials.gov Identifier:
NCT00544050
First Posted: October 16, 2007
Last Update Posted: November 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 4 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 15, 2007
First Posted: October 16, 2007
Last Update Posted: November 15, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs