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Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

Primary Purpose

Epilepsy

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Seletracetam (ucb 44212)
Sponsored by
UCB Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Partial Onset, Primary Generalized Seizures, Seletracetam

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65. Minimum body weight of 40 kg. Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months. Patients must be receiving 1 - 3 concomitant AEDs. Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method. Exclusion Criteria: Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted). Status epilepticus within 3 months of Visit 1. History of non-epileptic seizures. Patients on vigabatrin. Patients on felbamate, unless treatment has been continuous for ≥ 18 months. Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs. Ongoing psychiatric disease other than mild controlled disorders. Patients with a clinically significant organ dysfunction. Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients. Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety profile of seletracetam

    Secondary Outcome Measures

    Reduction in seizure frequency

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    March 19, 2012
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00175864
    Brief Title
    Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.
    Official Title
    Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2006 (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 is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    Partial Onset, Primary Generalized Seizures, Seletracetam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Seletracetam (ucb 44212)
    Primary Outcome Measure Information:
    Title
    Safety profile of seletracetam
    Secondary Outcome Measure Information:
    Title
    Reduction in seizure frequency

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    Inclusion Criteria: An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65. Minimum body weight of 40 kg. Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months. Patients must be receiving 1 - 3 concomitant AEDs. Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method. Exclusion Criteria: Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted). Status epilepticus within 3 months of Visit 1. History of non-epileptic seizures. Patients on vigabatrin. Patients on felbamate, unless treatment has been continuous for ≥ 18 months. Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs. Ongoing psychiatric disease other than mild controlled disorders. Patients with a clinically significant organ dysfunction. Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients. Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.
    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

    Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

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