Trial record 2 of 2 for:
NCT00464269
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
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ClinicalTrials.gov Identifier: NCT00150800 |
Recruitment Status :
Completed
First Posted : September 8, 2005
Results First Posted : December 5, 2018
Last Update Posted : June 1, 2020
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Sponsor:
UCB PHARMA Inc. (US)
Information provided by (Responsible Party):
UCB Pharma ( UCB PHARMA Inc. (US) )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Epilepsy |
Intervention |
Drug: Brivaracetam |
Enrollment | 668 |
Participant Flow
Recruitment Details | The study started to enroll patients in January 2006 and concluded in September 2017. 668 subjects were included in the Enrolled Set but 1 subject from India lost to follow up and was excluded from the Safety Analysis Set due to lack of medical data. |
Pre-assignment Details | The Participant Flow refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug. |
Arm/Group Title | Brivaracetam |
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Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis. |
Period Title: Overall Study | |
Started | 667 |
Completed | 171 |
Not Completed | 496 |
Reason Not Completed | |
Adverse Event | 89 |
Death | 18 |
Lack of Efficacy | 166 |
Lost to Follow-up | 58 |
Subject's choice | 90 |
No compliance | 18 |
IP misshandling | 1 |
Site closure | 24 |
Protocol non-adherence | 2 |
Nobody to accompany patient | 1 |
Distance too long for patient | 1 |
Neurosurgery | 2 |
BRV monotherapy | 1 |
Visit refusal | 3 |
Sponsor's request | 2 |
Generalized Epilepsy | 1 |
Moved from area/country | 8 |
PI retiring | 2 |
PI leaving site | 2 |
Patient insurance | 1 |
Surgical intervention | 4 |
Pregnancy planned | 1 |
PI discontinuation request | 1 |
Baseline Characteristics
Arm/Group Title | Brivaracetam | |
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Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis. | |
Overall Number of Baseline Participants | 667 | |
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The Baseline Characteristics refers to the Safety Analysis Set which included 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 | 667 participants | |
<=18 years |
30 4.5%
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Between 18 and 65 years |
632 94.8%
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>=65 years |
5 0.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 667 participants | |
34.3 (12.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 667 participants | |
Female |
303 45.4%
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Male |
364 54.6%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 667 participants | |
American Indian/Alaskan Native |
21 3.1%
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Asian |
206 30.9%
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Black |
18 2.7%
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Native Hawaiian Or Other Pacific Islander |
1 0.1%
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White |
361 54.1%
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Other/Mixed |
60 9.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844 599 ext 2273 |
EMail: | UCBCares@ucb.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma ( UCB PHARMA Inc. (US) ) |
ClinicalTrials.gov Identifier: | NCT00150800 |
Other Study ID Numbers: |
N01199 |
First Submitted: | September 6, 2005 |
First Posted: | September 8, 2005 |
Results First Submitted: | September 18, 2018 |
Results First Posted: | December 5, 2018 |
Last Update Posted: | June 1, 2020 |