Phase 3
Completed N=198
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Source: ClinicalTrials.gov NCT02337751 ↗Enrolled (actual)
198
Serious AEs
4.7%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) — 51; 91 Participants
◆ Published Evidence
Emerging
17citations · ~2 / year
Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson's disease.
Summary
The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.
Linked Publications
-
Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
51; 91 | — |
| SECONDARY Number of Participants With TEAE Related to Clinical Laboratory Tests |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Markedly Abnormal Vital Signs Values |
13; 30; 0; 1; 3; 3 | — |
| SECONDARY Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged) |
1; 1 | — |
| SECONDARY Number of Participants With TEAE Related to Body Weight (Weight Loss) |
1; 0 | — |
| SECONDARY Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score |
-2.8; -2.8 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has completed the preceding study.
- The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.
Exclusion Criteria
- The participant has undergone blood collection of >= 400 mL within 90 days prior to the start of treatment in this study.
- The participant is required to take any of the excluded medications or treatments.
- The participant is required surgery or hospitalization for surgery during the study period.
Data sourced from ClinicalTrials.gov (NCT02337751) and the linked publication. 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.