Status:
COMPLETED
Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT01479530
Start Date
December 1 2011
End Date
June 1 2013
Last Update
September 10 2018
Active Locations (18)
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1
CN015
Beijing, China, 100034
2
CN008
Beijing, China, 100050
3
CN017
Beijing, China, 100050
4
CN001
Beijing, China, 100730