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Trial record 1 of 1 for:    NCT00422110
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A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory 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.
 
ClinicalTrials.gov Identifier: NCT00422110
Recruitment Status : Withdrawn
First Posted : January 15, 2007
Last Update Posted : May 28, 2012
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsies, Partial Drug: Seletracetam Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Study Start Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
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
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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
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Study Director: Barbara Bennett, PhD UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00422110    
Other Study ID Numbers: N01272
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012
Keywords provided by UCB Pharma:
Seletracetam
Epilepsies
Partial
Epilepsy
Focal
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations