|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01061567 |
|
Date of registration:
|
24/12/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice
|
|
Scientific title:
|
Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice |
|
Date of first enrolment:
|
November 2009 |
|
Target sample size:
|
1814 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01061567 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Austria
|
Croatia
|
Estonia
|
Kazakhstan
|
Latvia
|
Romania
|
Serbia
|
Slovakia
|
|
Slovenia
| | | | | | | |
|
Contacts
|
|
Name:
|
Boehringer Ingelheim |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boehringer Ingelheim |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson's Disease
|
|
Primary Outcome(s)
|
|
Incidence of Adverse Events
[Time Frame: From the treatment initiation to the end of study, on average 92.9 days]
|
|
Proportion of Patients With Withdrawals Due to Adverse Events.
[Time Frame: 16 weeks]
|
|
Secondary Outcome(s)
|
|
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
[Time Frame: Baseline and the end of study (up to 16 weeks)]
|
|
Clinical Global Impression of Improvement (CGI-I) Responder Rate
[Time Frame: Baseline and the end of study (up to 16 weeks)]
|
|
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
[Time Frame: Baseline and the end of study (up to 16 weeks)]
|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
[Time Frame: Baseline and the end of study (up to 16 weeks)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|