Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
NCT ID: NCT00152503
Last Updated: 2023-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2005-08-31
2006-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Seletracetam
Escalating doses twice daily were to be administered.
Seletracetam (UCB44212)
* Pharmaceutical form: oral capsules
* Concentration: 2, 10 and 50 mg
* Route of administration: oral administration
Interventions
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Seletracetam (UCB44212)
* Pharmaceutical form: oral capsules
* Concentration: 2, 10 and 50 mg
* Route of administration: oral administration
Eligibility Criteria
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Inclusion Criteria
* Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
* Subjects who have been treated for epilepsy for \>= 6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of levetiracetam (LEV)
* Female subjects without childbearing potential or those who are using an acceptable contraceptive method
Exclusion Criteria
* Subjects on vigabatrin
* Subjects on felbamate, unless treatment has been continuous for \>2 years
* Ongoing psychiatric disease other than mild controlled disorders
* Subjects with clinically significant organ dysfunction
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs).
18 Years
65 Years
ALL
No
Sponsors
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UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB (+1 844 599 2273)
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
St. Petersburg, Florida, United States
Springfield, Illinois, United States
Wichita, Kansas, United States
Detroit, Michigan, United States
Chesterfield, Missouri, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Charlottesville, Virginia, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Calgary, , Canada
Montreal, , Canada
Countries
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Other Identifiers
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N01192
Identifier Type: -
Identifier Source: org_study_id
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