Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152451
First received: September 7, 2005
Last updated: September 30, 2008
Last verified: September 2008

September 7, 2005
September 30, 2008
May 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 NCT00152451 on ClinicalTrials.gov Archive Site
Safety and tolerability
Same as current
Not Provided
Not Provided
 
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
An Open-Label, Exploratory, Multicenter, Dose-Escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs

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
30
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).
  • Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal 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.
  • Subjects currently taking levetiracetam (LEV).
  • 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
 
NCT00152451
N01191
Not Provided
Not Provided
UCB, Inc.
Not Provided
Study Director: Barbara Bennett, PhD UCB, Inc.
UCB, Inc.
September 2008

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