Clinical trial NCT01556165: Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Rasagiline
Azilect
Parkinson´s Disease
Motor fluctuations
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 130
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic PD.
* Patients with a Modified Hoehn and Yahr stage \<3.

Exclusion Criteria:

* Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
* 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.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline to Week 26 in UPDRS Total Score
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)
timeFrame: Baseline to Week 26
measure: Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)
timeFrame: Baseline to Week 26
measure: Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)
timeFrame: Baseline to Week 26
measure: Time to Onset of Levodopa Therapy
timeFrame: Baseline to Week 26
measure: Levodopa Administration Within 26 Weeks
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: CN015
city: Beijing
country: China
facility: CN001
city: Chengdu
country: China
facility: CN011
city: Guangzhou
country: China
facility: CN003
city: Guangzhou
country: China
facility: CN005
city: Guangzhou
country: China
facility: CN017
city: Hangzhou
country: China
facility: CN004
city: Shanghai
country: China
facility: CN012
city: Shanghai
country: China
facility: CN007
city: Shanghai
country: China
facility: CN013
city: Suzhou
country: China
facility: CN006
city: Wuhan
country: China
facility: CN009
city: Wuhan
country: China
facility: CN016
city: Xi'an
country: China
facility: CN010
city: Xi'an
country: China
facility: CN014
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.