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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01479530 |
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Date of registration:
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22/11/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
CHORAL |
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Scientific title:
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Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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321 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01479530 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Email contact via H. Lundbeck A/S |
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Address:
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Telephone:
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Email:
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Affiliation:
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LundbeckClinicalTrials@lundbeck.com |
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Key inclusion & exclusion criteria
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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.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Azilect®
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change From Baseline in UPDRS Motor Score During ON Time
[Time Frame: Baseline and Week 16]
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Clinical Status Using CGI-I Score During ON Time
[Time Frame: Week 16]
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Change From Baseline in UPDRS-ADL Score During OFF Time
[Time Frame: Baseline and Week 16]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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