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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Levodopa; Rasagiline

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.