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

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ClinicalTrials.gov Identifier: NCT00544050
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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
Study Start Date : September 2002
Primary Completion Date : May 2003
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources




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


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

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00544050     History of Changes
Other Study ID Numbers: N01052
First Posted: October 16, 2007    Key Record Dates
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