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Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Primary Purpose

Epilepsy, Partial

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Japan Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Partial focused on measuring Epilepsy, partial, Keppra, Levetiracetam

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059 Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients. Exclusion Criteria: Patients who had not participate in N165 Clinical Trial of L059. Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication. Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Levetiracetam

    Arm Description

    Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

    Outcomes

    Primary Outcome Measures

    Partial (Type I) Seizure Frequency Per Week by Analysis Visit
    Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
    Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
    Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
    Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
    Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
    Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
    Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

    Secondary Outcome Measures

    Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
    Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
    Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
    Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
    Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.

    Full Information

    First Posted
    September 8, 2005
    Last Updated
    March 8, 2019
    Sponsor
    UCB Japan Co. Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00160615
    Brief Title
    Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
    Official Title
    Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 12, 2001 (Actual)
    Primary Completion Date
    January 17, 2007 (Actual)
    Study Completion Date
    January 17, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCB Japan Co. Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Partial
    Keywords
    Epilepsy, partial, Keppra, Levetiracetam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levetiracetam
    Arm Type
    Experimental
    Arm Description
    Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam
    Other Intervention Name(s)
    Keppra
    Intervention Description
    Pharmaceutical form: Film-coating tablets Concentration: 250 mg/ 500 mg Route of administration: oral use
    Primary Outcome Measure Information:
    Title
    Partial (Type I) Seizure Frequency Per Week by Analysis Visit
    Description
    Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
    Time Frame
    From Baseline up to 54 months
    Title
    Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
    Description
    Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
    Time Frame
    From Baseline up to 54 months
    Title
    Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
    Description
    Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
    Time Frame
    From Baseline up to 54 months
    Title
    Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
    Description
    Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.
    Time Frame
    From Baseline up to 54 months
    Secondary Outcome Measure Information:
    Title
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit
    Description
    Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Time Frame
    From Baseline up to 54 months
    Title
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit
    Description
    Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Time Frame
    From Baseline up to 54 months
    Title
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit
    Description
    Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Time Frame
    From Baseline up to 54 months
    Title
    Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit
    Description
    Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline.
    Time Frame
    From Baseline up to 54 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059 Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients. Exclusion Criteria: Patients who had not participate in N165 Clinical Trial of L059. Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication. Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Cares
    Organizational Affiliation
    001 844 599 2273 (UCB)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
    Description
    FDA Safety Alerts and Recalls

    Learn more about this trial

    Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

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