A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00367432
First received: August 21, 2006
Last updated: January 26, 2012
Last verified: January 2012
Results First Received: December 2, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epilepsies
Partial
Intervention: Drug: Levetiracetam

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levetiracetam Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Baseline Measures
    Levetiracetam  
Number of Participants  
[units: participants]
  398  
Age  
[units: years]
Mean ± Standard Deviation
  33.68  ± 11.18  
Age, Customized  
[units: participants]
 
Between 16 and 65 years     398  
Gender  
[units: participants]
 
Female     196  
Male     202  
Race/Ethnicity, Customized  
[units: Participants]
 
Japanese     396  
Asian (other than Japanese)     2  
Region of Enrollment  
[units: participants]
 
Japan     398  
Weight  
[units: Kilogram¬†(kg)]
Mean ± Standard Deviation
  60.39  ± 13.64  



  Outcome Measures
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1.  Primary:   Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)   [ Time Frame: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted ]

2.  Secondary:   Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]

3.  Secondary:   Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study   [ Time Frame: First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16) ]

4.  Secondary:   Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]

5.  Secondary:   Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]

6.  Secondary:   Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]

7.  Secondary:   Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]

8.  Secondary:   Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]

9.  Secondary:   Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study   [ Time Frame: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00367432     History of Changes
Other Study ID Numbers: N01222
Study First Received: August 21, 2006
Results First Received: December 2, 2011
Last Updated: January 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency