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
  Purpose

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


Condition Intervention Phase
Epilepsy, Partial
Drug: Seletracetam (ucb 44212)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Reduction in seizure frequency over 11-week treatment period

Secondary Outcome Measures:
  • Safety and Tolerability

Estimated Enrollment: 60
Study Start Date: August 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152503

Locations
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
Study Director: Barbara Bennett, PhD UCB Pharma
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00152503     History of Changes
Other Study ID Numbers: N01192
Study First Received: September 7, 2005
Last Updated: September 30, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by UCB Pharma:
Epilepsy, Partial Onset Seizures, Seletracetam

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Anticonvulsants
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014