Back to resultsA Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
Primary Purpose
Epilepsies, Partial
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Seletracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsies, Partial focused on measuring Seletracetam, Epilepsies, Partial, Epilepsy, Focal
Eligibility 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
Sites / Locations
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00422110
Brief Title
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
May 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
Seletracetam, Epilepsies, Partial, Epilepsy, Focal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Seletracetam
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Bennett, PhD
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
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