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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00422110
First Posted: January 15, 2007
Last Update Posted: May 28, 2012
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.
Information provided by:
UCB Pharma
  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
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 Pharma:

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

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.


Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00422110


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

ClinicalTrials.gov Identifier: NCT00422110     History of Changes
Other Study ID Numbers: N01272
First Submitted: January 11, 2007
First Posted: January 15, 2007
Last Update Posted: May 28, 2012
Last Verified: May 2012

Keywords provided by UCB Pharma:
Seletracetam
Epilepsies
Partial
Epilepsy
Focal

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms