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

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: March 13, 2012
Last updated: December 27, 2013
Last verified: December 2013

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.

Condition Intervention Phase
Parkinson's Disease
Drug: rasagiline
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Resource links provided by NLM:

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change from baseline to 26 weeks in Unified Parkinson's Disease Rating Scale (UPDRS) total score in patients with early PD not treated with levodopa [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 26 weeks in sub-scale scores of the UPDRS (part I, II, and III) [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]
  • Time to onset of levodopa therapy [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]
  • Levodopa administration within 26 weeks [ Time Frame: baseline to 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: April 2012
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rasagiline Drug: rasagiline
1 mg/day, tablets, once daily, orally
Other Name: Azilect
Placebo Comparator: placebo Drug: placebo
tablets, once daily, orally


Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01556165

Beijing, China, 100730
Beijing, China, 100034
Chengdu, China, 610041
Guangzhou, China, 510120
Guangzhou, China, 510180
Hangzhou, China, 310009
Shanghai, China, 200127
Shanghai, China, 200025
Shanghai, China, 200040
Suzhou, China, 215004
Wuhan, China, 430022
Wuhan, China, 430030
Xi'an, China, 710032
Zi'an, China, 710061
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S Identifier: NCT01556165     History of Changes
Other Study ID Numbers: 13485A
Study First Received: March 13, 2012
Last Updated: December 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Parkinson´s Disease
Motor fluctuations

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 25, 2014