Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01261325
First received: December 9, 2010
Last updated: July 4, 2016
Last verified: July 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: Drug: Placebo
Drug: Brivaracetam
Drug: Antiepileptic drugs with market authorization available per country

  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
Recruitment for the N01358 study began in December 2010. The study concluded in May 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow and Baseline Demographics data is taken from the Randomized Set (RS). The RS consists of all subjects who were randomized.

Reporting Groups
  Description
Placebo Matching placebo tablets administered twice daily
Brivaracetam 100 mg/Day Brivaracetam 50 mg administered twice daily
Brivaracetam 200 mg/Day Brivaracetam 100 mg administered twice daily

Participant Flow:   Overall Study
    Placebo     Brivaracetam 100 mg/Day     Brivaracetam 200 mg/Day  
STARTED     263     254     251  
COMPLETED     246     225     225  
NOT COMPLETED     17     29     26  
Lack of Efficacy                 1                 1                 0  
Withdrawal by Subject                 2                 2                 4  
SAE, non-fatal                 1                 5                 1  
AE, non-serious non-fatal                 9                 15                 13  
SAE, non-fatal+AE, non-serious non-fatal                 0                 1                 1  
Non Compliance                 2                 0                 0  
Patient Randomized by Mistake                 0                 1                 0  
Erroneously Randomized                 1                 0                 0  
Screen Failure                 1                 0                 0  
Randomized in Error                 0                 0                 1  
Protocol Violation                 0                 3                 1  
Lost to Follow-up                 0                 1                 3  
AE, serious fatal                 0                 0                 2  



  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 consist of the Randomized Set (RS). The RS includes all subjects that were randomized.

Reporting Groups
  Description
Placebo Matching placebo tablets administered twice daily
Brivaracetam 100 mg/Day Brivaracetam 50 mg administered twice daily
Brivaracetam 200 mg/Day Brivaracetam 100 mg administered twice daily
Total Title No text entered.

Baseline Measures
    Placebo     Brivaracetam 100 mg/Day     Brivaracetam 200 mg/Day     Total Title  
Number of Participants  
[units: participants]
  263     254     251     768  
Age  
[units: years]
Mean (Standard Deviation)
  39.8  (12.8)     39.0  (13.4)     39.7  (12.8)     39.5  (13.0)  
Gender  
[units: participants]
       
Female     128     152     117     397  
Male     135     102     134     371  
Weight  
[units: kilograms]
Median (Standard Deviation)
  76.1  (19.9)     74.1  (16.8)     75.5  (19.0)     75.2  (18.6)  
Height  
[units: centimeters]
Mean (Standard Deviation)
  168.4  (10.0)     166.6  (9.8)     168.7  (9.9)     167.9  (9.9)  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  26.6  (5.7)     26.7  (5.6)     26.4  (6.0)     26.6  (5.8)  
Racial Group  
[units: participants]
       
American Indian or Alaska Native     10     8     11     29  
Asian     32     32     29     93  
Black or African American     11     8     7     26  
White     190     183     183     556  
Other     17     21     18     56  
Missing     3     2     3     8  



  Outcome Measures
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1.  Primary:   Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration   [ Time Frame: 12 week Treatment Period ]

2.  Primary:   50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration   [ Time Frame: Baseline to 12 week Treatment Period ]

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

4.  Secondary:   Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period   [ Time Frame: Baseline to 12 week Treatment Period ]

5.  Secondary:   Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period   [ Time Frame: 12 week Treatment Period ]

6.  Secondary:   All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period   [ Time Frame: 12 week Treatment Period ]

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

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

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


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01261325     History of Changes
Other Study ID Numbers: N01358
2010-019361-28 ( EudraCT Number )
Study First Received: December 9, 2010
Results First Received: March 14, 2016
Last Updated: July 4, 2016
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Ministry of Social Affairs and Health
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Italy: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health and Consumption
Sweden: The National Board of Health and Welfare
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration