Trial record 1 of 3 for:
NCT00490035
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
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ClinicalTrials.gov Identifier: NCT00490035 |
Recruitment Status :
Completed
First Posted : June 22, 2007
Results First Posted : April 13, 2016
Last Update Posted : July 21, 2022
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Sponsor:
UCB Pharma SA
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Epilepsy |
Interventions |
Other: Placebo Drug: Brivaracetam |
Enrollment | 399 |
Participant Flow
Recruitment Details | This study started to enroll subjects in September 2007 and concluded in February 2009. |
Pre-assignment Details | Participant Flow refers to the Randomized Set. |
Arm/Group Title | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day |
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Matching Placebo tablets administered twice a day | Brivaracetam 20 mg/day, 10 mg administered twice a day | Brivaracetam 50 mg/day, 25 mg administered twice a day | Brivaracetam 100 mg/day, 50 mg administered twice a day |
Period Title: Overall Study | ||||
Started | 100 | 99 | 100 | 100 |
Completed | 92 | 93 | 88 | 94 |
Not Completed | 8 | 6 | 12 | 6 |
Reason Not Completed | ||||
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 |
Serious adverse event (SAE), non-fatal | 0 | 0 | 1 | 0 |
AE of unknown type | 0 | 0 | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day | Total Title | |
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Matching Placebo tablets administered twice a day | Brivaracetam 20 mg/day, 10 mg administered twice a day | Brivaracetam 50 mg/day, 25 mg administered twice a day | Brivaracetam 100 mg/day, 50 mg administered twice a day | [Not Specified] | |
Overall Number of Baseline Participants | 100 | 99 | 100 | 100 | 399 | |
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Baseline Characteristics refer to the Randomized Set.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 100 participants | 99 participants | 100 participants | 100 participants | 399 participants | |
36.4 (13.0) | 35.7 (12.5) | 39.0 (13.5) | 38.0 (13.1) | 37.24 (13.05) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 100 participants | 99 participants | 100 participants | 100 participants | 399 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 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | 99 participants | 100 participants | 100 participants | 399 participants | |
Female |
46 46.0%
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38 38.4%
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45 45.0%
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42 42.0%
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171 42.9%
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Male |
54 54.0%
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61 61.6%
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55 55.0%
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58 58.0%
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228 57.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 100 participants | 99 participants | 100 participants | 100 participants | 399 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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB Clinical Trial Call Center |
Organization: | UCB |
Phone: | +1 877 822 9493 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma ( UCB Pharma SA ) |
ClinicalTrials.gov Identifier: | NCT00490035 |
Other Study ID Numbers: |
N01252 2006-006344-59 ( EudraCT Number ) |
First Submitted: | June 21, 2007 |
First Posted: | June 22, 2007 |
Results First Submitted: | March 14, 2016 |
Results First Posted: | April 13, 2016 |
Last Update Posted: | July 21, 2022 |