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

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ClinicalTrials.gov Identifier: NCT01479530
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : June 26, 2014
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
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. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Placebo Drug: Azilect® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Once daily; tablet; orally; 16 weeks

Experimental: Azilect® Drug: Azilect®
1 mg daily; tablet; orally; 16 weeks
Other Name: Rasagiline




Primary Outcome Measures :
  1. Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 ]

    Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.

    The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time.



Secondary Outcome Measures :
  1. Clinical Status Using CGI-I Score During ON Time [ Time Frame: Week 16 ]
    Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).

  2. Change From Baseline in UPDRS-ADL Score During OFF Time [ Time Frame: Baseline and Week 16 ]
    Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).

  3. Change From Baseline in UPDRS Motor Score During ON Time [ Time Frame: Baseline and Week 16 ]
    UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479530


Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01479530    
Other Study ID Numbers: 13445A
First Posted: November 24, 2011    Key Record Dates
Results First Posted: June 26, 2014
Last Update Posted: September 10, 2018
Last Verified: August 2018
Keywords provided by H. Lundbeck A/S:
Rasagiline
Azilect
Parkinson´s Disease
Motor fluctuations
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs