Phase 3
Completed N=130
Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Source: ClinicalTrials.gov NCT01556165 ↗Enrolled (actual)
130
Serious AEs
3.1%
Results posted
Dec 2014
Primary outcomePrimary: Change From Baseline to Week 26 in UPDRS Total Score — -0.18; -3.18 units on a scale — p=0.0254
Summary
Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 26 in UPDRS Total Score |
-0.18; -3.18 | 0.0254 sig |
| SECONDARY Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I) |
0.08; -0.54 | 0.0032 sig |
| SECONDARY Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II) |
0.25; -0.43 | 0.1963 |
| SECONDARY Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III) |
-0.52; -2.23 | 0.0641 |
| SECONDARY Time to Onset of Levodopa Therapy |
— | — |
| SECONDARY Levodopa Administration Within 26 Weeks |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with idiopathic PD.
- Patients with a Modified Hoehn and Yahr stage <3.
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 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 (NCT01556165). 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.