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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01556165
First received: March 13, 2012
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01556165

Locations
China
CN015
Beijing, China, 100034
CN001
Beijing, China, 100730
CN011
Chengdu, China, 610041
CN003
Guangzhou, China, 510120
CN005
Guangzhou, China, 510180
CN004
Hangzhou, China, 310009
CN013
Shanghai, China, 200127
CN012
Shanghai, China, 200025
CN007
Shanghai, China, 200040
CN006
Suzhou, China, 215004
CN009
Wuhan, China, 430022
CN016
Wuhan, China, 430030
CN010
Xi'an, China, 710032
CN014
Zi'an, China, 710061
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov 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:
Rasagiline
Azilect
Parkinson´s Disease
Motor fluctuations

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Rasagiline
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 26, 2014