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Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00160615
First received: September 8, 2005
Last updated: March 3, 2015
Last verified: September 2009
  Purpose
The safety and efficacy of L059 will be evaluated in patients who completed "N165 Clinical Trial of L059". They will receive L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

Condition Intervention Phase
Epilepsy, Partial
Drug: levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Frequency of AE/ADR

Secondary Outcome Measures:
  • Seizures frequency per week

Estimated Enrollment: 97
Study Start Date: September 2001
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
  2. Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion Criteria:

  1. Patients who had not participate in N165 Clinical Trial of L059.
  2. Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
  3. Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
  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: NCT00160615

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00160615     History of Changes
Other Study ID Numbers: N01020  L05/EPI/LG1/FN/01 
Study First Received: September 8, 2005
Last Updated: March 3, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Epilepsy, Partial,
Keppra, levetiracetam

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016