N/A
Completed N=615
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
Source: ClinicalTrials.gov NCT01525641 ↗Enrolled (actual)
615
Serious AEs
5.3%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Adverse Drug Reactions — 24.78 percentage of participants
Summary
Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Adverse Drug Reactions |
24.78 | — |
| SECONDARY Clinical Global Impression of Effect |
14; 223; 205; 67 | — |
| SECONDARY Change From Baseline in Total Score of the UPDRS Part III to Last Observation |
-3.73 | — |
| SECONDARY Change From Baseline in the Modified Hoehn & Yahr to Last Observation |
-0.12 | — |
| SECONDARY Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA |
43; 262; 2 | — |
| SECONDARY Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA |
144; 163 | — |
Eligibility Criteria
Inclusion criteria
- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.
Exclusion criteria
- None
Data sourced from ClinicalTrials.gov (NCT01525641). 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.