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Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

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ClinicalTrials.gov Identifier: NCT01405508
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : April 13, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: Brivaracetam tablets
Drug: Brivaracetam bolus
Drug: Brivaracetam infusion
Other: Placebo

  Participant Flow

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 recruit patients in August 2011 and concluded in July 2012.

105 subjects were randomized to 4 different treatment groups.


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 (RS).

Reporting Groups
  Description
Placebo Tablets / Brivaracetam Bolus

Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week

Placebo Tablets / Brivaracetam Infusion

Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week

Brivaracetam (BRV) Tablets / BRV Bolus

Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week

Brivaracetam (BRV) Tablets / BRV Infusion

Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week


Participant Flow:   Overall Study
    Placebo Tablets / Brivaracetam Bolus   Placebo Tablets / Brivaracetam Infusion   Brivaracetam (BRV) Tablets / BRV Bolus   Brivaracetam (BRV) Tablets / BRV Infusion
STARTED   26   26   27   26 
COMPLETED   25   25   27   26 
NOT COMPLETED   1   1   0   0 
AE, non-serious non-fatal                1                1                0                0 



  Baseline Characteristics

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 Characetristics refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.

Reporting Groups
  Description
Placebo Tablets / Brivaracetam Bolus

Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week

Placebo Tablets / Brivaracetam Infusion

Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week

Brivaracetam (BRV) Tablets / BRV Bolus

Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week

Brivaracetam (BRV) Tablets / BRV Infusion

Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.

Down-Titration:

  • If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
  • If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:

Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week

Total Title No text entered.

Baseline Measures
   Placebo Tablets / Brivaracetam Bolus   Placebo Tablets / Brivaracetam Infusion   Brivaracetam (BRV) Tablets / BRV Bolus   Brivaracetam (BRV) Tablets / BRV Infusion   Total Title 
Overall Participants Analyzed 
[Units: Participants]
 26   26   27   26   105 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      26 100.0%      25  96.2%      27 100.0%      25  96.2%      103  98.1% 
>=65 years      0   0.0%      1   3.8%      0   0.0%      1   3.8%      2   1.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.6  (12.2)   39.5  (14.4)   42.0  (9.2)   44.4  (12.6)   41.6  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      12  46.2%      10  38.5%      17  63.0%      17  65.4%      56  53.3% 
Male      14  53.8%      16  61.5%      10  37.0%      9  34.6%      49  46.7% 


  Outcome Measures

1.  Primary:   Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days)   [ Time Frame: 40 days ]

2.  Secondary:   Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)   [ Time Frame: 40 days ]

3.  Secondary:   Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period.   [ Time Frame: 4.5-day Evaluation Period ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 Cares
phone: +1 887 822 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01405508     History of Changes
Other Study ID Numbers: N01258
2008-004714-27 ( EudraCT Number )
First Submitted: July 27, 2011
First Posted: July 29, 2011
Results First Submitted: March 14, 2016
Results First Posted: April 13, 2016
Last Update Posted: July 11, 2018