Phase 3
Completed N=321
Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Source: ClinicalTrials.gov NCT01479530 ↗Enrolled (actual)
321
Serious AEs
3.7%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary — -0.76; -1.25 hours — p=0.0228
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary |
-0.76; -1.25 | 0.0228 sig |
| SECONDARY Clinical Status Using CGI-I Score During ON Time |
3.56; 3.15 | <0.0001 sig |
| SECONDARY Change From Baseline in UPDRS-ADL Score During OFF Time |
-1.20; -2.21 | 0.0075 sig |
| SECONDARY Change From Baseline in UPDRS Motor Score During ON Time |
-1.75; -3.34 | 0.0317 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01479530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.