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 Pharma
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The Full Analysis Set (FAS) includes all subjects to whom the investigational products are assigned after registration, excluding those with serious Good Clinical Practice violations , subjects not administered the investigational products and subjects for whom no data is available after assignment of the investigational products.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Eligible subjects from preceding study N01221 [NCT00280696] entered the First Period of this study and those subjects from N01221 [NCT00280696] who completed the First Period and subjects from the study N01020 [NCT00160615] entered the Second Period.

Participant Flow and Baseline Characteristics refer to the FAS.


Reporting Groups
  Description
Levetiracetam N01221 [NCT00280696] N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
Levetiracetam N01020 [NCT00160615] N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.

Participant Flow for 2 periods

Period 1:   First Period (16 Weeks)
    Levetiracetam N01221 [NCT00280696]     Levetiracetam N01020 [NCT00160615]  
STARTED     313 [1]   0  
COMPLETED     275     0  
NOT COMPLETED     38     0  
Adverse Event                 6                 0  
Lack of Efficacy                 24                 0  
Withdrawal by Subject                 6                 0  
Other Reason                 2                 0  
[1] Eligible subjects from preceding study N01221 [NCT00280696] entered the First Period of N01222

Period 2:   Second Period (up to 54 Months)
    Levetiracetam N01221 [NCT00280696]     Levetiracetam N01020 [NCT00160615]  
STARTED     275 [1]   85 [2]
COMPLETED     188     69  
NOT COMPLETED     87     16  
Adverse Event                 14                 3  
Lack of Efficacy                 59                 5  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 8                 5  
Other Reason                 6                 2  
[1] 275 subjects from N01221 [NCT00280696] completed First Period and entered Second Period of N01222
[2] 85 subjects from N01020 [NCT00160615] entered Second Period of N01222



  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 ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Measure Description

Change in complex partial seizure frequency is given as a percent reduction computed as:

[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.

Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.

Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

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  
Safety Issue No  

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.
Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.

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).

Measured Values
    Levetiracetam  
Number of Participants Analyzed  
[units: participants]
  285  
Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study  
[units: Percent Reduction]
Median ( Inter-Quartile Range )
  20.59  
  ( -15.24 to 52.94 )  

No statistical analysis provided for Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period 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


  Limitations and Caveats
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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.


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