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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Azilect®

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • CN015
  • Beijing, China, 100730
    • CN001
  • Beijing, China, 100050
    • CN008
  • Beijing, China, 100050
    • CN017
  • Beijing, China, 100730
    • CN018
  • Chengdu, China, 610041
    • CN011
  • Guangzhou, China, 510120
    • CN003
  • Guangzhou, China, 510180
    • CN005
  • Hangzhou, China, 310009
    • CN004
  • Qingyu Zhou, China, 510260
    • CN019
  • Qingyu Zhou, China, 510260
    • CN020
  • Shanghai, China, 200025
    • CN012
  • Shanghai, China, 200040
    • CN007
  • Shanghai, China, 200127
    • CN013
  • Suzhou, China, 215004
    • CN006
  • Wuhan, China, 430022
    • CN009
  • Xi'an, China, 710032
    • CN010
  • Zi'an, China, 710061
    • CN014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Once daily; tablet; orally; 16 weeks
Experimental: Azilect®	Drug: Azilect®; 1 mg daily; tablet; orally; 16 weeks; Other Names: Rasagiline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Status Using CGI-I Score During ON Time	Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).	Week 16
Change From Baseline in UPDRS-ADL Score During OFF Time	Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).	Baseline and Week 16
Change From Baseline in UPDRS Motor Score During ON Time	UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).	Baseline and Week 16

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Rasagiline; Azilect; Motor fluctuations; Parkinson´s Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: 13445A