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Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)
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.
Age
30 - 75 years
Sex
ALL
Healthy Volunteers
No
CN002
Chengdu, China
CN005
Chenzhou, China
CN007
Chongqing, China
CN003
Guilin, China
CN004
Lanzhou, China
CN006
Luzhou, China
CN008
Nanjing, China
CN001
Xi'an, China
Start Date
November 1, 2011
Primary Completion Date
June 1, 2013
Completion Date
June 1, 2013
Last Updated
September 13, 2013
268
ACTUAL participants
Rasagiline
DRUG
Placebo
DRUG
Lead Sponsor
Chongqing Fortune Pharmaceutical Co., Ltd.
Collaborators
Data Source & Attribution
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