Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: September 6, 2005
Last updated: September 16, 2013
Last verified: September 2009

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures

Condition Intervention Phase
Generalized Epilepsy
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number and percentage of subjects having at least six months of seizure freedom

Secondary Outcome Measures:
  • Number and percentage of subjects remaining seizure-free, for all seizures and by seizure type, from the beginning of the trial until the last on-treatment visit.
  • Safety and tolerability
  • Quality of Life

Estimated Enrollment: 300
Study Start Date: November 2001
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam
  • Subjects who were/are suffering from primary generalized (type II) epileptic seizures
  • Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected.

Exclusion Criteria:

  • Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
  • Concomitant use of any drug with possible central nervous system effects unless at a stable dose.
  • Concomitant use of any drug (other than hormonal treatment and the subject's normal AED(s)) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time.
  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 identifier: NCT00150748

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877-822-9493
  More Information

Additional Information:
No publications provided by UCB Pharma

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00150748     History of Changes
Other Study ID Numbers: N167, EudraCT 2004-001997-13
Study First Received: September 6, 2005
Last Updated: September 16, 2013
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
New Zealand: Food Safety Authority
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Generalized Epilepsy, Primary Generalized Seizures
Keppra, Levetiracetam

Additional relevant MeSH terms:
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015