Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Lundbeck

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: rasagiline

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01556165

13485A

Details and patient eligibility

About

Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.

The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.

Enrollment

130 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with idiopathic PD.
Patients with a Modified Hoehn and Yahr stage <3.

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 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.