Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

Study Overview
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Brief Summary
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The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Official Title
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Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: Azilect®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with idiopathic PD. Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours. Patients with a Modified Hoehn and Yahr stage ≤3 in the ON state. Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline. Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa. Patients 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 with a clinically significant or unstable vascular disease. Patients who have undergone a neurosurgical intervention of PD. Patients with severe disabling dyskinesias. 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. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Once daily; tablet; orally; 16 weeks<br>|
| Experimental: Azilect®<br> | Drug: Azilect®<br>* 1 mg daily; tablet; orally; 16 weeks<br>* Other names: Rasagiline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 4, 8, 12, and 16, and the Baseline Total Daily OFF Time. | Baseline and Weeks 4, 8, 12, and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week 16 | 
| 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 worse 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). | Baseline and Week 16 | 
| 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 worse 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). | Baseline and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations