Clinical trial NCT01479530: Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations 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: 2011-11-24
Enrollment: 321
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic PD.
* 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 medical or surgical condition that would preclude his/her safe and complete study participation.
* 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.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
timeFrame: Baseline and Weeks 4, 8, 12, and 16
Secondary outcomes:
measure: Clinical Status Using CGI-I Score During ON Time
timeFrame: Week 16
measure: Change From Baseline in UPDRS-ADL Score During OFF Time
timeFrame: Baseline and Week 16
measure: Change From Baseline in UPDRS Motor Score During ON Time
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: CN015
city: Beijing
country: China
facility: CN008
city: Beijing
country: China
facility: CN017
city: Beijing
country: China
facility: CN001
city: Beijing
country: China
facility: CN018
city: Chengdu
country: China
facility: CN011
city: Guangzhou
country: China
facility: CN003
city: Guangzhou
country: China
facility: CN005
city: Hangzhou
country: China
facility: CN004
city: Qingyu Zhou
country: China
facility: CN019
city: Qingyu Zhou
country: China
facility: CN020
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: Xi'an
country: China
facility: CN010
city: Zi'an
country: China
facility: CN014
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.