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
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Study Type | Interventional |
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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 |
Enrollment | 105 |
Recruitment Details |
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 | Participant Flow refers to the Randomized Set (RS). |
Arm/Group Title | Placebo Tablets / Brivaracetam Bolus | Placebo Tablets / Brivaracetam Infusion | Brivaracetam (BRV) Tablets / BRV Bolus | Brivaracetam (BRV) Tablets / BRV Infusion |
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Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days. 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 |
Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days. 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 |
Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days. 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 |
Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days. 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 |
Period Title: Overall Study | ||||
Started | 26 | 26 | 27 | 26 |
Completed | 25 | 25 | 27 | 26 |
Not Completed | 1 | 1 | 0 | 0 |
Reason Not Completed | ||||
AE, non-serious non-fatal | 1 | 1 | 0 | 0 |
Arm/Group Title | Placebo Tablets / Brivaracetam Bolus | Placebo Tablets / Brivaracetam Infusion | Brivaracetam (BRV) Tablets / BRV Bolus | Brivaracetam (BRV) Tablets / BRV Infusion | Total Title | |
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Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days. 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 |
Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days. 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 |
Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days. 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 |
Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days. 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 |
[Not Specified] | |
Overall Number of Baseline Participants | 26 | 26 | 27 | 26 | 105 | |
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Baseline Characetristics refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 26 participants | 26 participants | 27 participants | 26 participants | 105 participants | |
<=18 years |
0 0.0%
|
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
26 100.0%
|
25 96.2%
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27 100.0%
|
25 96.2%
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103 98.1%
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>=65 years |
0 0.0%
|
1 3.8%
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0 0.0%
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1 3.8%
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2 1.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 26 participants | 26 participants | 27 participants | 26 participants | 105 participants | |
40.6 (12.2) | 39.5 (14.4) | 42.0 (9.2) | 44.4 (12.6) | 41.6 (12.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 26 participants | 26 participants | 27 participants | 26 participants | 105 participants | |
Female |
12 46.2%
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10 38.5%
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17 63.0%
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17 65.4%
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56 53.3%
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Male |
14 53.8%
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16 61.5%
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10 37.0%
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9 34.6%
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49 46.7%
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Name/Title: | UCB (Study Director) |
Organization: | UCB Cares |
Phone: | +1 887 822 9493 |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT01405508 |
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 |