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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01479530
First received: November 22, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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. [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline after 16 weeks of treatment on Clinical Global Impression - Improvement (CGI-I) score during "ON" time [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline after 16 weeks of treatment on UPDRS Motor score during "ON" time [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 321
Study Start Date: December 2011
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rasagiline Drug: rasagiline
1 mg/day, once daily, tablets, orally
Other Name: Azilect
Placebo Comparator: placebo Drug: placebo
once daily, tablets, orally

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479530

Locations
China
CN015
Beijing, China, 100034
CN017
Beijing, China, 100050
CN018
Beijing, China, 100730
CN001
Beijing, China, 100730
CN008
Beijing, China, 100050
CN011
Chengdu, China, 610041
CN019
Guang Zhou, China, 510260
CN020
Guang Zhou, China, 510260
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
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: NCT01479530     History of Changes
Other Study ID Numbers: 13445A
Study First Received: November 22, 2011
Last Updated: September 11, 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 April 17, 2014