Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
NCT ID: NCT01479530
Last Updated: 2018-09-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2011-12-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
NCT01268891
Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
NCT01556165
Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations
NCT01736891
A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
NCT00399477
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
NCT01765257
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Once daily; tablet; orally; 16 weeks
Azilect®
Azilect®
1 mg daily; tablet; orally; 16 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Once daily; tablet; orally; 16 weeks
Azilect®
1 mg daily; tablet; orally; 16 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CN015
Beijing, , China
CN008
Beijing, , China
CN017
Beijing, , China
CN001
Beijing, , China
CN018
Beijing, , China
CN011
Chengdu, , China
CN003
Guangzhou, , China
CN005
Guangzhou, , China
CN004
Hangzhou, , China
CN019
Qingyu Zhou, , China
CN020
Qingyu Zhou, , China
CN012
Shanghai, , China
CN007
Shanghai, , China
CN013
Shanghai, , China
CN006
Suzhou, , China
CN009
Wuhan, , China
CN010
Xi'an, , China
CN014
Zi’an, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhang Z, Shao M, Chen S, Liu C, Peng R, Li Y, Wang J, Zhu S, Qu Q, Zhang X, Chen H, Sun X, Wang Y, Sun S, Zhang B, Li J, Pan X, Zhao G. Adjunct rasagiline to treat Parkinson's disease with motor fluctuations: a randomized, double-blind study in China. Transl Neurodegener. 2018 Jun 30;7:14. doi: 10.1186/s40035-018-0119-7. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13445A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.