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Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Azilect®
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Azilect, Motor fluctuations, Parkinson´s Disease, Rasagiline

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with idiopathic PD
  • Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours (not including morning akinesia)
  • Patients with a Modified Hoehn and Yahr stage <5 in the OFF state
  • Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline
  • Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
  • Patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation

Exclusion Criteria:

  • Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation
  • Patients taking any disallowed medication according to the Azilect® approved label
  • Patients taking MAO inhibitors within 3 months prior to baseline visit
  • Patients with a known serious adverse reaction to selegiline
  • Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study
  • Patients with a Mini Mental State Examination (MMSE) score <=24
  • Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Azilect®

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
    Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time.

    Secondary Outcome Measures

    Clinical Status Using CGI-I Score During ON Time
    Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).
    Change From Baseline in UPDRS-ADL Score During OFF Time
    Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).
    Change From Baseline in UPDRS Motor Score During ON Time
    UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

    Full Information

    First Posted
    December 30, 2010
    Last Updated
    October 7, 2013
    Sponsor
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01268891
    Brief Title
    Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
    Official Title
    Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    H. Lundbeck A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.
    Detailed Description
    Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of Azilect®, a monoamine oxidase type B (MAO-B) inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations. Azilect® is approved for treatment of PD in Europe and the US. The objective of this study is to evaluate the efficacy, tolerability, and safety of Azilect® compared to placebo in Korean PD patients with motor fluctuations on levodopa therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Azilect, Motor fluctuations, Parkinson´s Disease, Rasagiline

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    132 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Azilect®
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Once daily; tablet; orally; 18 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Azilect®
    Other Intervention Name(s)
    Rasagiline
    Intervention Description
    1 mg daily; tablet; orally; 18 weeks
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
    Description
    Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time.
    Time Frame
    Baseline and Weeks 6, 10, 14, and 18
    Secondary Outcome Measure Information:
    Title
    Clinical Status Using CGI-I Score During ON Time
    Description
    Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).
    Time Frame
    Week 18
    Title
    Change From Baseline in UPDRS-ADL Score During OFF Time
    Description
    Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).
    Time Frame
    Baseline and Week 18
    Title
    Change From Baseline in UPDRS Motor Score During ON Time
    Description
    UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).
    Time Frame
    Baseline and Week 18

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with idiopathic PD Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours (not including morning akinesia) Patients with a Modified Hoehn and Yahr stage <5 in the OFF state Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa Patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation Exclusion Criteria: Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation Patients taking any disallowed medication according to the Azilect® approved label Patients taking MAO inhibitors within 3 months prior to baseline visit Patients with a known serious adverse reaction to selegiline Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study Patients with a Mini Mental State Examination (MMSE) score <=24 Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Email contact via H. Lundbeck A/S
    Organizational Affiliation
    LundbeckClinicalTrials@lundbeck.com
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea

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