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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00419393 |
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Date of registration:
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04/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
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Scientific title:
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An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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190 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00419393 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Poland
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Russian Federation
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United States
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Contacts
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Name:
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UCB Clinical Trial Call Center, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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+1 877 822 9493 (UCB) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week
up titration period
Exclusion Criteria:
- Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
- Subjects who were discontinued prior to the end of titration period
Age minimum:
12 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Drug: Keppra XR (Levetiracetam XR)
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Primary Outcome(s)
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Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period
[Time Frame: Duration of the Treatment Period (6 months-2 years)]
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Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
[Time Frame: Duration of the Treatment Period (6 months-2 years)]
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Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)
[Time Frame: Duration of the Treatment Period (6 months-2 years)]
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Secondary Outcome(s)
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Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months
[Time Frame: Study entry through 12 months]
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Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months
[Time Frame: Study entry through 6 months]
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Secondary ID(s)
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2007-000899-17
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N01281
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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