Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations

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

Summary

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

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

Details

• Lead Sponsor: Chongqing Fortune Pharmaceutical Co., Ltd.
• Collaborator: Beijing Bionovo Medicine Development Co., Ltd.
• Treatments: Levodopa; Rasagiline

Criteria

Inclusion Criteria:

• Patients with idiopathic PD

• Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose

• Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state

• Patient with motor fluctuations averaging at least 2 hour daily in the OFF state

• Patients who have demonstrated the ability to keep accurate 24-hour diaries

Exclusion Criteria:

• Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia

• Patients with severe cognitive impairment judged by a Mini Mental State Examination

• Patients with a clinically significant psychiatric illness

• Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10

• Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation

• Patients with a clinically significant or unstable vascular disease

• Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply