N/A
Completed N=1,814
Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice
Source: ClinicalTrials.gov NCT01061567 ↗Enrolled (actual)
1,814
Serious AEs
0.2%
Results posted
Jul 2014
Primary outcomePrimary: Incidence of Adverse Events — 105; 56 participants
Summary
The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
105; 56 | — |
| PRIMARY Proportion of Patients With Withdrawals Due to Adverse Events. |
0.019 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score |
1.1; 10.6 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) Responder Rate |
84.3 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction |
18.5 | — |
| SECONDARY Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score |
0.6 | — |
Eligibility Criteria
Inclusion criteria
- Early and advanced idiopathic Parkinson's disease
- Male and female patients over 18 years of age
- Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)
Exclusion criteria
- Ongoing treatment with pramipexole ER
- Exclusion criteria in line with the pramipexole ER SmPC:
In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.
Data sourced from ClinicalTrials.gov (NCT01061567). 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.