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

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ClinicalTrials.gov Identifier: NCT00160615
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 4, 2015
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy, Partial Drug: levetiracetam Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Study Start Date : September 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007





Primary Outcome Measures :
  1. Frequency of AE/ADR

Secondary Outcome Measures :
  1. Seizures frequency per week


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT00160615


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00160615     History of Changes
Other Study ID Numbers: N01020
L05/EPI/LG1/FN/01
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: September 2009

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