Trial record 1 of 1 for:
NCT01506882
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
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ClinicalTrials.gov Identifier: NCT01506882 |
Recruitment Status :
Completed
First Posted : January 10, 2012
Results First Posted : October 13, 2014
Last Update Posted : December 31, 2015
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Sponsor:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
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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 |
Conditions |
Epilepsy Partial Onset Seizures |
Intervention |
Drug: Levetiracetam (LEV) |
Enrollment | 71 |
Participant Flow
Recruitment Details | This multicenter study started to enroll subjects in December 2011 in order to end up with 27 centers with enrolled subjects in Japan. |
Pre-assignment Details | Participant Flow refers to the Randomized Set (RS). RS consists of all subjects who were randomized to the study groups. |
Arm/Group Title | Levetiracetam 1000 mg/Day to 2000 mg/Day Group | Levetiracetam 3000 mg/Day Group |
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Period Title: Overall Study | ||
Started | 61 | 10 |
Completed | 39 | 3 |
Not Completed | 22 | 7 |
Reason Not Completed | ||
Lack of Efficacy | 4 | 3 |
Lost to Follow-up | 1 | 0 |
Withdrawal by Subject | 9 | 3 |
SAE, non-fatal | 2 | 0 |
AE, non-serious non-fatal | 3 | 1 |
SAE,non-fatal+AE,non-serious non-fatal | 1 | 0 |
Other Reason | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Levetiracetam 1000 mg/Day to 2000 mg/Day Group | Levetiracetam 3000 mg/Day Group | Total Title | |
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[Not Specified] | |
Overall Number of Baseline Participants | 61 | 10 | 71 | |
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Baseline Characteristics refer to the Safety Set (SS). SS consists of all subjects in the Enrolled Set, who received at least 1 dose of the Investigational Medicinal Product (IMP).
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 61 participants | 10 participants | 71 participants | |
<=18 years |
10 16.4%
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1 10.0%
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11 15.5%
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Between 18 and 65 years |
45 73.8%
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8 80.0%
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53 74.6%
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>=65 years |
6 9.8%
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1 10.0%
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7 9.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 61 participants | 10 participants | 71 participants | |
36.5 (18.0) | 37.0 (18.6) | 36.5 (17.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 61 participants | 10 participants | 71 participants | |
Female |
34 55.7%
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4 40.0%
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38 53.5%
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Male |
27 44.3%
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6 60.0%
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33 46.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Japan | Number Analyzed | 61 participants | 10 participants | 71 participants |
61 | 10 | 71 | ||
Weight
Mean (Standard Deviation) Unit of measure: Kilogram (kg) |
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Number Analyzed | 61 participants | 10 participants | 71 participants | |
58.98 (12.30) | 62.58 (15.11) | 59.48 (12.67) | ||
Height
Mean (Standard Deviation) Unit of measure: Centimeter (cm) |
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Number Analyzed | 61 participants | 10 participants | 71 participants | |
161.96 (8.77) | 166.07 (10.21) | 162.54 (9.02) |
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 |
Responsible Party: | UCB Pharma ( UCB Japan Co. Ltd. ) |
ClinicalTrials.gov Identifier: | NCT01506882 |
Other Study ID Numbers: |
N01375 2014-004377-16 ( EudraCT Number ) |
First Submitted: | January 5, 2012 |
First Posted: | January 10, 2012 |
Results First Submitted: | October 7, 2014 |
Results First Posted: | October 13, 2014 |
Last Update Posted: | December 31, 2015 |