A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00422110
First received: January 11, 2007
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.


Condition Intervention Phase
Epilepsies, Partial
Drug: Seletracetam
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIb/III, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Seletracetam as Adjunctive Treatment in Subjects (≥16 to 70 Years Old) With Refractory Partial Onset Seizures.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs

Secondary Outcome Measures:
  • Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)

Enrollment: 0
Study Start Date: May 2008
  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects from 16 to 70 years old
  • Confirmed diagnosis of focal epilepsy
  • Partial seizures uncontrolled while taking 1 or 2 AEDs
  • At least 8 partial seizures during the 8-week baseline period

Exclusion Criteria:

  • Seizures occurring only in clusters
  • Status epilepticus within 1 year
  • Progressive CNS disorder
  • Other serious or uncontrolled diseases
  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: NCT00422110

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Barbara Bennett, PhD UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422110     History of Changes
Other Study ID Numbers: N01272
Study First Received: January 11, 2007
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Seletracetam
Epilepsies
Partial
Epilepsy
Focal

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014