The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
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 rasagiline, a 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. The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
268
Tablets, qd
Tablets, qd
CN002
Chengdu, China
CN005
Chenzhou, China
CN007
Chongqing, China
CN003
Guilin, China
CN004
Efficacy of rasagiline vs placebo as assessed by the change from baseline to week 14 in mean total daily OFF time measured by patients' home diaries in levodopa-treated PD patients with motor fluctuations.
Time frame: 0, 14 weeks
Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.
Time frame: 0, 6, 10, 16 weeks
Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.
Time frame: 0, 6, 14, 16 weeks
Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living.
Time frame: 0, 6, 14, 16 weeks
Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries.
Time frame: 0, 6, 10, 14, 16 weeks
Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.
Time frame: 0, 6, 14, 16 weeks
The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.
Time frame: 0, 2, 6, 14, 16 weeks
BP、 temperature、 breath and heart rate after 5 minutes of stasis.
Time frame: -2, 0, 2, 6, 10, 14, 16 weeks
Physical examination.
Time frame: -2, 16 weeks
Adverse Events: the occurrence of melanoma.
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Lanzhou, China
CN006
Luzhou, China
CN008
Nanjing, China
CN001
Xi'an, China
Time frame: 0, 2, 6, 10, 14, 16 weeks
Grade of UPDRS I
Time frame: 0, 6, 14, 16 weeks
Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.
Time frame: 0, 6, 16 weeks