Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease|
- Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.
- Level of Adherence [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]Points on Morisky scale
- Patient Preference [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]Patients were asked about their preference regarding frequency of intake (once daily or three times daily)
- Adverse Events (AE) Considered Related to Observed Medication [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]Some patients had not related AEs as well as related AEs.
- Pramipexole (PPX) Dose [ Time Frame: pre-treatment and after 8-12 weeks ] [ Designated as safety issue: No ]mean Pramipexole (PPX) dose
- Clinical Global Impressions (CGI) [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]Clinical Global Impression (CGI) scale at final visit
- Patients Global Impressions (PGI) [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.
|Study Start Date:||March 2010|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Patient with parkinsons disease||Drug: Pramipexole Extended Release|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097421
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|