Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
NCT ID: NCT01556165
Last Updated: 2014-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2012-04-30
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 Chinese PD patients not treated with levodopa.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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rasagiline
rasagiline
1 mg/day, tablets, once daily, orally
placebo
placebo
tablets, once daily, orally
Interventions
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rasagiline
1 mg/day, tablets, once daily, orally
placebo
tablets, once daily, orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a Modified Hoehn and Yahr stage \<3.
Exclusion Criteria
* Patients with a clinically significant or unstable vascular disease.
* 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.
35 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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CN015
Beijing, , China
CN001
Beijing, , China
CN011
Chengdu, , China
CN003
Guangzhou, , China
CN005
Guangzhou, , China
CN017
Guangzhou, , China
CN004
Hangzhou, , China
CN012
Shanghai, , China
CN007
Shanghai, , China
CN013
Shanghai, , China
CN006
Suzhou, , China
CN009
Wuhan, , China
CN016
Wuhan, , China
CN010
Xi'an, , China
CN014
Xi'an, , China
Countries
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References
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Zhang Z, Wang J, Chen S, Liu C, Zhang B, Peng R, Sun S, Sun X, Zhao G, Qu Q, Li Y, Zhu S, Pan X, Shao M, Wang Y. Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study. Transl Neurodegener. 2018 Dec 6;7:32. doi: 10.1186/s40035-018-0137-5. eCollection 2018.
Other Identifiers
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13485A
Identifier Type: -
Identifier Source: org_study_id