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
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
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
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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