N/A
N=416
Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT00613301 ↗Enrolled (actual)
416
Serious AEs
8.4%
Results posted
Nov 2010
Primary outcome: Primary: Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events — 51.7; 41.3; 8.4 Proportion (percentage of participants)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events |
51.7; 41.3; 8.4 | — |
| SECONDARY Clinical Global Impression of Improvement |
19; 137; 97; 15; 71 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score |
-5.2 | — |
| SECONDARY Change From Baseline in Modified Hoehn & Yahr Rating Scale |
-0.1 | — |
Summary
The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.
Eligibility Criteria
Inclusion Criteria
Patients with Parkinson's disease who do not receive L-Dopa supplementation
Exclusion Criteria
Patients should have been treated according to the Japanese insert slip
Data sourced from ClinicalTrials.gov (NCT00613301). 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.