Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT00490035
First received: June 21, 2007
Last updated: March 14, 2016
Last verified: March 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Other: Placebo
Drug: Brivaracetam

  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
This study started to enroll subjects in September 2007 and concluded in February 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow refers to the Randomized Set.

Reporting Groups
  Description
Placebo Matching Placebo tablets administered twice a day
Brivaracetam 20 mg/Day Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/Day Brivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam 100 mg/Day Brivaracetam 100 mg/day, 50 mg administered twice a day

Participant Flow:   Overall Study
    Placebo     Brivaracetam 20 mg/Day     Brivaracetam 50 mg/Day     Brivaracetam 100 mg/Day  
STARTED     100     99     100     100  
COMPLETED     92     93     88     94  
NOT COMPLETED     8     6     12     6  
AE, non-serious non-fatal                 3                 4                 4                 5  
Lost to Follow-up                 2                 0                 1                 0  
Withdrawal by Subject                 2                 1                 1                 0  
Other reason                 0                 1                 3                 1  
AE, serious fatal                 1                 0                 0                 0  
SAE, non-fatal                 0                 0                 1                 0  
AE of unknown type                 0                 0                 2                 0  



  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.
Baseline Characteristics refer to the Randomized Set.

Reporting Groups
  Description
Placebo Matching Placebo tablets administered twice a day
Brivaracetam 20 mg/Day Brivaracetam 20 mg/day, 10 mg administered twice a day
Brivaracetam 50 mg/Day Brivaracetam 50 mg/day, 25 mg administered twice a day
Brivaracetam 100 mg/Day Brivaracetam 100 mg/day, 50 mg administered twice a day
Total Title No text entered.

Baseline Measures
    Placebo     Brivaracetam 20 mg/Day     Brivaracetam 50 mg/Day     Brivaracetam 100 mg/Day     Total Title  
Number of Participants  
[units: participants]
  100     99     100     100     399  
Age  
[units: years]
Mean (Standard Deviation)
  36.4  (13.0)     35.7  (12.5)     39.0  (13.5)     38.0  (13.1)     37.24  (13.05)  
Age, Customized  
[units: participants]
         
<18 years     2     2     0     1     5  
Between 18 and 65 years     96     94     97     96     383  
>=65 years     2     3     3     3     11  
Gender  
[units: participants]
         
Female     46     38     45     42     171  
Male     54     61     55     58     228  
Region of Enrollment  
[units: Participants]
         
Hungary     4     2     3     3     12  
Poland     26     28     27     27     108  
India     23     22     23     23     91  
Belgium     3     0     3     0     6  
Finland     3     3     1     4     11  
France     17     17     11     15     60  
Germany     8     10     14     9     41  
Italy     4     8     3     5     20  
Netherlands     3     0     1     3     7  
Spain     8     4     6     4     22  
Switzerland     1     3     6     5     15  
United Kingdom     0     2     2     2     6  



  Outcome Measures
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1.  Primary:   Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

2.  Secondary:   Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

3.  Secondary:   All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

4.  Secondary:   Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week   [ Time Frame: From Baseline to 12-week Treatment Period ]

5.  Secondary:   Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

6.  Secondary:   Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

7.  Secondary:   Time to First Type I Seizure During the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

8.  Secondary:   Time to Fifth Type I Seizure During the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

9.  Secondary:   Time to Tenth Type I Seizure During the 12-week Treatment Period   [ Time Frame: From Baseline to 12-week Treatment Period ]

10.  Secondary:   Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

11.  Secondary:   Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

12.  Secondary:   Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

13.  Secondary:   Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

14.  Secondary:   Change From Baseline to the 12-week Treatment Period in Hospital Depression Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

15.  Secondary:   Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit   [ Time Frame: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period ]

16.  Secondary:   Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit   [ Time Frame: Last Visit or Early Discontinuation Visit in the 12-week Treatment Period ]

17.  Secondary:   Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

18.  Secondary:   Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

19.  Secondary:   Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

20.  Secondary:   Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

21.  Secondary:   Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

22.  Secondary:   Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score   [ Time Frame: From Baseline to 12-week Treatment Period ]

23.  Secondary:   Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.   [ Time Frame: From Baseline to 12-week Treatment Period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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.


  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.


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


Publications of Results:

Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00490035     History of Changes
Other Study ID Numbers: N01252
2006-006344-59 ( EudraCT Number )
Study First Received: June 21, 2007
Results First Received: March 14, 2016
Last Updated: March 14, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Switzerland: Swissmedic
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India