Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations. The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
1 mg/day, tablets, once daily, orally
tablets, once daily, orally
CN015
Beijing, China
CN001
Beijing, China
CN011
Chengdu, China
CN003
Guangzhou, China
Change From Baseline to Week 26 in UPDRS Total Score
The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
Time frame: Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)
Time frame: Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)
Time frame: Baseline to Week 26
Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)
Time frame: Baseline to Week 26
Time to Onset of Levodopa Therapy
It was stated in the statistical analysis plan (SAP) that if \>10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
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CN005
Guangzhou, China
CN017
Guangzhou, China
CN004
Hangzhou, China
CN012
Shanghai, China
CN007
Shanghai, China
CN013
Shanghai, China
...and 5 more locations
Time frame: Baseline to Week 26
Levodopa Administration Within 26 Weeks
It was stated in the statistical analysis plan (SAP) that if \>10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.
Time frame: Baseline to Week 26