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This study has been withdrawn prior to enrollment.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
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 April 16, 2014