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A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

This study has been terminated.
(An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00699283
First received: June 12, 2008
Last updated: November 21, 2016
Last verified: November 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: 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 multi-Center study started to enroll subjects in August 2008 and concluded in March 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow refers to the Randomized Set (RS). Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of "Adverse Event" or "Lack of efficacy" as reported by the Investigator.

Reporting Groups
  Description
Brivaracetam (BRV) 50 mg 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
Brivaracetam (BRV) 100 mg 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).

Participant Flow:   Overall Study
    Brivaracetam (BRV) 50 mg   Brivaracetam (BRV) 100 mg
STARTED   47   15 
COMPLETED   14   7 
NOT COMPLETED   33   8 
Lack of Efficacy                15                5 
Lost to Follow-up                2                0 
Withdrawal by Subject                1                0 
Other Reason                5                1 
SAE, non-fatal                1                1 
AE, non-serious non-fatal                8                1 
AE of unknown type                1                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 Intent-to-Treat Set (ITT), consisting of all randomized subjects with at least 1 intake of study medication.

Reporting Groups
  Description
Brivaracetam (BRV) 50 mg 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
Brivaracetam (BRV) 100 mg 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
Total Title No text entered.

Baseline Measures
   Brivaracetam (BRV) 50 mg   Brivaracetam (BRV) 100 mg   Total Title 
Overall Participants Analyzed 
[Units: Participants]
 47   15   62 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 Years      45  95.7%      14  93.3%      59  95.2% 
>=65 years      2   4.3%      1   6.7%      3   4.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.0  (13.8)   44.3  (15.9)   40.3  (14.4) 
Gender 
[Units: Participants]
Count of Participants
     
Female      27  57.4%      11  73.3%      38  61.3% 
Male      20  42.6%      4  26.7%      24  38.7% 


  Outcome Measures

1.  Primary:   The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase   [ Time Frame: From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks) ]


  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 (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00699283     History of Changes
Other Study ID Numbers: N01306
RPCE07F1216
2008-000145-58 ( EudraCT Number )
Study First Received: June 12, 2008
Results First Received: March 14, 2016
Last Updated: November 21, 2016