Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00150748
First received: September 6, 2005
Last updated: September 9, 2009
Last verified: September 2009
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Purpose
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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
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) |
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
Criteria
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 More Information
No publications provided by UCB, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00150748 History of Changes |
| Other Study ID Numbers: | N167, EudraCT 2004-001997-13 |
| Study First Received: | September 6, 2005 |
| Last Updated: | September 9, 2009 |
| Health Authority: | Austria: Federal Ministry for Health and Women Belgium: Directorate general for the protection of Public health: Medicines 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, Inc.:
|
Generalized Epilepsy, Primary Generalized Seizures Keppra, Levetiracetam |
Additional relevant MeSH terms:
|
Epilepsy Epilepsy, Generalized Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Etiracetam |
Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013