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Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00152503
First received: September 7, 2005
Last updated: September 30, 2008
Last verified: September 2008

September 7, 2005
September 30, 2008
August 2005
January 2007   (final data collection date for primary outcome measure)
Reduction in seizure frequency over 11-week treatment period
Same as current
Complete list of historical versions of study NCT00152503 on ClinicalTrials.gov Archive Site
Safety and Tolerability
Same as current
Not Provided
Not Provided
 
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
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

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Epilepsy, Partial
Drug: Seletracetam (ucb 44212)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2007
January 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00152503
N01192
Not Provided
Not Provided
UCB Pharma
Not Provided
Study Director: Barbara Bennett, PhD UCB Pharma
UCB Pharma
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP