Phase 3
Completed N=132
Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
Source: ClinicalTrials.gov NCT01268891 ↗Enrolled (actual)
132
Serious AEs
6.8%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary — -1.24; -1.59 hours — p=0.3257
Summary
To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary |
-1.24; -1.59 | 0.3257 |
| SECONDARY Clinical Status Using CGI-I Score During ON Time |
3.35; 3.05 | 0.0946 |
| SECONDARY Change From Baseline in UPDRS-ADL Score During OFF Time |
0.13; -0.57 | 0.2258 |
| SECONDARY Change From Baseline in UPDRS Motor Score During ON Time |
-1.52; -2.87 | 0.1700 |
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 (not including morning akinesia)
- Patients with a Modified Hoehn and Yahr stage <5 in the OFF state
- Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline
- Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
- Patient 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 taking any disallowed medication according to the Azilect® approved label
- Patients taking MAO inhibitors within 3 months prior to baseline visit
- Patients with a known serious adverse reaction to selegiline
- 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
Data sourced from ClinicalTrials.gov (NCT01268891). 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.