Trial record 1 of 1 for:
NCT00160654
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
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ClinicalTrials.gov Identifier: NCT00160654 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
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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: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Epilepsy, Partial |
Intervention |
Drug: Levetiracetam |
Enrollment | 251 |
Participant Flow
Recruitment Details | The study started to enroll patients in November 2003 and concluded in May 2006. |
Pre-assignment Details | Participant Flow refers to the Intend-to-treat (ITT) Set. |
Arm/Group Title | Levetiracetam |
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Subjects received open-label Levetiracetam. |
Period Title: Overall Study | |
Started | 251 |
Completed | 218 |
Not Completed | 33 |
Reason Not Completed | |
Adverse Event | 14 |
Lack of Efficacy | 4 |
Lost to Follow-up | 2 |
Intake of expired drug | 7 |
Psychological trauma | 1 |
Sponsor decision | 1 |
Patient met exclusion criteria | 1 |
Patient decision | 1 |
Poor compliance, dilantin toxicity | 1 |
Met exclusion criteria | 1 |
Baseline Characteristics
Arm/Group Title | Levetiracetam | |
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Subjects received open-label Levetiracetam. | |
Overall Number of Baseline Participants | 251 | |
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Baseline characteristics refer to the Intend-to-treat (ITT) Set.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 251 participants | |
<=18 years |
10 4.0%
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Between 18 and 65 years |
240 95.6%
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>=65 years |
1 0.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 251 participants | |
34.42 (11.21) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 251 participants | |
Female |
137 54.6%
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Male |
114 45.4%
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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 |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00160654 |
Other Study ID Numbers: |
N01036 |
First Submitted: | September 8, 2005 |
First Posted: | September 12, 2005 |
Results First Submitted: | February 8, 2018 |
Results First Posted: | August 19, 2020 |
Last Update Posted: | August 19, 2020 |