Trial record 1 of 1 for:
NCT00698581
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
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ClinicalTrials.gov Identifier: NCT00698581 |
Recruitment Status :
Terminated
(An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.)
First Posted : June 17, 2008
Results First Posted : April 13, 2016
Last Update Posted : July 11, 2018
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Epilepsy |
Intervention |
Drug: Brivaracetam |
Enrollment | 88 |
Participant Flow
Recruitment Details | This study started to enroll patients in August 2008 and concluded in February 2010. |
Pre-assignment Details | 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 Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of "Adverse Event" or "Lack of efficacy" as reported by the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. |
Arm/Group Title | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day |
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Brivaracetam: 25 mg tablet - 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: 25 mg tablet - 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) |
Period Title: Overall Study | ||
Started | 68 | 20 |
Completed | 23 | 8 |
Not Completed | 45 | 12 |
Reason Not Completed | ||
Lack of Efficacy | 23 | 11 |
Withdrawal by Subject | 6 | 0 |
Other reason | 9 | 1 |
SAE, non-fatal | 1 | 0 |
AE, non-serious non-fatal | 4 | 0 |
SAE, non-fatal+AE, non-serious non-fatal | 1 | 0 |
AE of unknown type | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day | Total Title | |
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Brivaracetam: 25 mg tablet - 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: 25 mg tablet - 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) | [Not Specified] | |
Overall Number of Baseline Participants | 68 | 20 | 88 | |
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Demographics refer to the Randomized Set (RS).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 68 participants | 20 participants | 88 participants | |
37.7 (11.7) | 43.6 (13.2) | 39.0 (12.2) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 68 participants | 20 participants | 88 participants |
< 65 years | 66 | 19 | 85 | |
>= 65 years | 2 | 1 | 3 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 20 participants | 88 participants | |
Female |
33 48.5%
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8 40.0%
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41 46.6%
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Male |
35 51.5%
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12 60.0%
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47 53.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB Cares |
Organization: | UCB |
Phone: | +1 877 822 9493 |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00698581 |
Other Study ID Numbers: |
N01276 2008-000144-14 ( EudraCT Number ) |
First Submitted: | June 12, 2008 |
First Posted: | June 17, 2008 |
Results First Submitted: | March 14, 2016 |
Results First Posted: | April 13, 2016 |
Last Update Posted: | July 11, 2018 |