Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu
Trial record 1 of 1 for:    NCT00152451
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152451
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : February 10, 2017
Information provided by:
UCB Pharma

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : May 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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

Secondary Outcome Measures :
  1. Safety and tolerability

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

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 identifier (NCT number): NCT00152451

Layout table for location information
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
San Francisco, California, United States, 94115
Stanford, California, United States, 94302
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Nashville, Tennessee, United States, 37212
United States, Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
UCB Pharma
Layout table for investigator information
Study Director: Barbara Bennett, PhD UCB Pharma
Layout table for additonal information Identifier: NCT00152451    
Other Study ID Numbers: N01191
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by UCB Pharma:
Epilepsy: partial onset seizures, seletracetam
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations