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Trial record 1 of 1 for:    NCT00152503
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Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

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ClinicalTrials.gov Identifier: NCT00152503
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : October 1, 2008
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
This trial will evaluate the efficacy and safety of ucb 44212 as add-on therapy in subjects with focal epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Seletracetam (ucb 44212) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label, Exploratory, Dose-Escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures
Study Start Date : August 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction in seizure frequency over 11-week treatment period

Secondary Outcome Measures :
  1. Safety and Tolerability

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
  • 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 LEV.
  • Female subjects without childbearing potential or those who are using an acceptable contraceptive method

Exclusion Criteria:

  • Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures
  • 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 AEDs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152503


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, Florida
St Petersburg, Florida, United States
United States, Illinois
Springfield, Illinois, United States
United States, Kansas
Witchita, Kansas, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Canada, Alberta
Edmonton, Alberta, Canada
Canada
Calgary, Canada
Montreal, Canada
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: Barbara Bennett, PhD UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00152503    
Other Study ID Numbers: N01192
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: September 2008
Keywords provided by UCB Pharma:
Epilepsy, Partial Onset Seizures, Seletracetam
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations