Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

Condition(s) targeted: Parkinson's Disease

Intervention: rasagiline (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

Overall contact:
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com

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. Rasagiline has been developed for the treatment of 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.

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: To evaluate the efficacy of a fixed dose of rasagiline (1 mg/day) vs. placebo as assessed by the change from baseline in mean total daily "OFF" time during 16 weeks of treatment in levodopa-treated PD patients with motor fluctuations.

Secondary outcome:

Change from baseline after 16 weeks of treatment on Clinical Global Impression - Improvement (CGI-I) score during "ON" time

Change from baseline after 16 weeks of treatment on Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) score during "OFF" time

Change from baseline after 16 weeks of treatment on UPDRS Motor score during "ON" time

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com

CN018, Beijing 100730, China; Recruiting

CN015, Beijing 100034, China; Recruiting

CN017, Beijing 100050, China; Recruiting

CN011, Chengdu 610041, China; Recruiting

CN019, Guang Zhou, China; Recruiting

CN003, Guangzhou 510120, China; Recruiting

CN005, Guangzhou 510180, China; Recruiting

CN004, Hangzhou 310009, China; Recruiting

CN013, Shanghai 200127, China; Recruiting

CN012, Shanghai 200025, China; Recruiting

CN006, Suzhou 215004, China; Recruiting

CN009, Wuhan 430022, China; Recruiting

CN010, Xi'an 710032, China; Recruiting

CN014, Zi'an 710061, China; Recruiting

Starting date: December 2011
Last updated: November 9, 2012