N/A
N=1,699
Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT01100073 ↗Enrolled (actual)
1,699
Serious AEs
0.2%
Results posted
Sep 2010
Primary outcome: Primary: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance — 5.20 Points on UPDRS scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance |
5.20 | — |
| PRIMARY Change From Baseline in UPDRS Part III Score at the End of Maintenance |
12 | — |
| PRIMARY Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) |
0.3 | — |
| PRIMARY Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) |
0.2 | — |
| PRIMARY Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) |
4.1 | — |
| PRIMARY Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance |
15 | — |
| SECONDARY Final Dose Distribution |
3.0 | — |
| SECONDARY Change From Baseline in UPDRS Part II Score at the End of Up-titration |
3.1 | — |
| SECONDARY Change From Baseline in UPDRS Part III Score at the End of Up-titration |
7.6 | — |
| SECONDARY Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration |
2.5 | — |
| SECONDARY Incidence, Relationship and Seriousness of Adverse Events |
266; 230; 3 | — |
| SECONDARY Number of Premature Discontinuations |
100 | — |
Summary
The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.
Eligibility Criteria
Inclusion Criteria
- Idiopathic Parkinson's disease with or without fluctuations
- Indication for treatment with pramipexole (Mirapexin®)
- Presence of at least mild tremor symptoms (as judged by the treating physician)
Exclusion Criteria
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with pramipexole (Mirapexin®)
Data sourced from ClinicalTrials.gov (NCT01100073). 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.