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

Lundbeck

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: Placebo

Drug: Azilect®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01479530

13445A

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Ages

30+ years old

Volunteers

No 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.