Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment [ Time Frame: 8-12 weeks ]
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 ]
Points on Morisky scale
Secondary Outcome Measures
Patient Preference [ Time Frame: 8-12 weeks ]
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 ]
Some patients had not related AEs as well as related AEs.
Pramipexole (PPX) Dose [ Time Frame: pre-treatment and after 8-12 weeks ]
mean Pramipexole (PPX) dose
Clinical Global Impressions (CGI) [ Time Frame: 8-12 weeks ]
Clinical Global Impression (CGI) scale at final visit
Patients Global Impressions (PGI) [ Time Frame: 8-12 weeks ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
30 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study
Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
Male or female PD patients aged at least 30
Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
Written informed consent by the patient for study participation.
Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement.
Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).