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Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China (CHORAL)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebo
Azilect®
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CN015
  • CN008
  • CN017
  • CN001
  • CN018
  • CN011
  • CN003
  • CN005
  • CN004
  • CN019
  • CN020
  • CN012
  • CN007
  • CN013
  • CN006
  • CN009
  • CN010
  • CN014

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Azilect®

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
November 22, 2011
Last Updated
August 10, 2018
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01479530
Brief Title
Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Acronym
CHORAL
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Rasagiline, Azilect, Parkinson´s Disease, Motor fluctuations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Azilect®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily; tablet; orally; 16 weeks
Intervention Type
Drug
Intervention Name(s)
Azilect®
Other Intervention Name(s)
Rasagiline
Intervention Description
1 mg daily; tablet; orally; 16 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
Description
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.
Time Frame
Baseline and Weeks 4, 8, 12, and 16
Secondary Outcome Measure Information:
Title
Clinical Status Using CGI-I Score During ON Time
Description
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).
Time Frame
Week 16
Title
Change From Baseline in UPDRS-ADL Score During OFF Time
Description
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).
Time Frame
Baseline and Week 16
Title
Change From Baseline in UPDRS Motor Score During ON Time
Description
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).
Time Frame
Baseline and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
CN015
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
CN008
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
CN017
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
CN001
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
CN018
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
CN011
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
CN003
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
CN005
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
CN004
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
CN019
City
Qingyu Zhou
ZIP/Postal Code
510260
Country
China
Facility Name
CN020
City
Qingyu Zhou
ZIP/Postal Code
510260
Country
China
Facility Name
CN012
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
CN007
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
CN013
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
CN006
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
CN009
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
CN010
City
Xi'an
ZIP/Postal Code
710032
Country
China
Facility Name
CN014
City
Zi'an
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29988514
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.
Results Reference
derived

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Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

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