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

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479530
• Other study ID #: 13445A
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Placebo
Once daily; tablet; orally; 16 weeks
• Azilect®
1 mg daily; tablet; orally; 16 weeks

Locations

Country	Name	City	State
China	CN001	Beijing
China	CN008	Beijing
China	CN015	Beijing
China	CN017	Beijing
China	CN018	Beijing
China	CN011	Chengdu
China	CN003	Guangzhou
China	CN005	Guangzhou
China	CN004	Hangzhou
China	CN019	Qingyu Zhou
China	CN020	Qingyu Zhou
China	CN007	Shanghai
China	CN012	Shanghai
China	CN013	Shanghai
China	CN006	Suzhou
China	CN009	Wuhan
China	CN010	Xi'an
China	CN014	Zi'an

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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