Trial record 1 of 1 for:
NCT00368251
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
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ClinicalTrials.gov Identifier: NCT00368251 |
Recruitment Status :
Completed
First Posted : August 24, 2006
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Unverricht-Lundborg Disease |
Interventions |
Other: Placebo Drug: BRV 2.5 mg Drug: BRV 25 mg Drug: BRV 50 mg |
Enrollment | 56 |
Participant Flow
Recruitment Details | 72 subjects were screened, 56 subjects were randomized. Participant Flow refers to all subjects randomized who are identical with the Intent-To-Treat (ITT) Population, which consists of all randomized subjects who took at least one dose of study medication. |
Pre-assignment Details |
Arm/Group Title | Placebo | Brivaracetam 5 mg/Day | Brivaracetam 150 mg/Day |
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Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) | Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) | Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period) |
Period Title: Overall Study | |||
Started | 18 | 20 | 18 |
Completed | 17 | 20 | 17 |
Not Completed | 1 | 0 | 1 |
Reason Not Completed | |||
SAE, non-fatal | 1 | 0 | 0 |
AE, non-serious non-fatal | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo | Brivaracetam 5 mg/Day | Brivaracetam 150 mg/Day | Total Title | |
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Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) | Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) | Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period) | [Not Specified] | |
Overall Number of Baseline Participants | 18 | 20 | 18 | 56 | |
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The Baseline Analysis Population contains all randomized subjects who are identical with the Intent-To-Treat (ITT) population.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 20 participants | 18 participants | 56 participants | |
<=18 years |
0 0.0%
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1 5.0%
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1 5.6%
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2 3.6%
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Between 18 and 65 years |
18 100.0%
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19 95.0%
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17 94.4%
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54 96.4%
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>=65 years |
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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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | 20 participants | 18 participants | 56 participants | |
34.3 (9.2) | 35.8 (10.9) | 33.7 (11.4) | 34.65 (10.38) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 20 participants | 18 participants | 56 participants | |
Female |
12 66.7%
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11 55.0%
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9 50.0%
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32 57.1%
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Male |
6 33.3%
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9 45.0%
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9 50.0%
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24 42.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 18 participants | 20 participants | 18 participants | 56 participants |
Serbia | 2 | 2 | 2 | 6 | |
France | 3 | 2 | 3 | 8 | |
United States | 2 | 3 | 4 | 9 | |
Canada | 4 | 3 | 2 | 9 | |
Finland | 3 | 4 | 2 | 9 | |
Russian Federation | 2 | 3 | 3 | 8 | |
Israel | 0 | 0 | 2 | 2 | |
Tunisia | 2 | 3 | 0 | 5 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB Cares |
Organization: | UCB |
Phone: | +1877 822 ext 9493 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00368251 |
Other Study ID Numbers: |
N01236 2006-001536-46 ( EudraCT Number ) |
First Submitted: | August 23, 2006 |
First Posted: | August 24, 2006 |
Results First Submitted: | March 14, 2016 |
Results First Posted: | April 13, 2016 |
Last Update Posted: | July 11, 2018 |