Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
CHORAL
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
1 other identifier
interventional
321
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2011
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
June 26, 2014
CompletedSeptember 10, 2018
August 1, 2018
1.5 years
November 22, 2011
May 23, 2014
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time.
Baseline and Weeks 4, 8, 12, and 16
Secondary Outcomes (3)
Clinical Status Using CGI-I Score During ON Time
Week 16
Change From Baseline in UPDRS-ADL Score During OFF Time
Baseline and Week 16
Change From Baseline in UPDRS Motor Score During ON Time
Baseline and Week 16
Study Arms (2)
Placebo
PLACEBO COMPARATORAzilect®
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (18)
CN015
Beijing, 100034, China
CN008
Beijing, 100050, China
CN017
Beijing, 100050, China
CN001
Beijing, 100730, China
CN018
Beijing, 100730, China
CN011
Chengdu, 610041, China
CN003
Guangzhou, 510120, China
CN005
Guangzhou, 510180, China
CN004
Hangzhou, 310009, China
CN019
Qingyu Zhou, 510260, China
CN020
Qingyu Zhou, 510260, China
CN012
Shanghai, 200025, China
CN007
Shanghai, 200040, China
CN013
Shanghai, 200127, China
CN006
Suzhou, 215004, China
CN009
Wuhan, 430022, China
CN010
Xi'an, 710032, China
CN014
Zi’an, 710061, China
Related Publications (1)
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.
PMID: 29988514DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- H. Lundbeck A/S
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2011
First Posted
November 24, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 10, 2018
Results First Posted
June 26, 2014
Record last verified: 2018-08