Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Pramipexole Extended Release


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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).

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with parkinsons disease<br> | Drug: Pramipexole Extended Release<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | 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. | 8-12 weeks | 
| Level of Adherence | Points on Morisky scale | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference | Patients were asked about their preference regarding frequency of intake (once daily or three times daily) | 8-12 weeks | 
| Adverse Events (AE) Considered Related to Observed Medication | Some patients had not related AEs as well as related AEs. | 8-12 weeks | 
| Pramipexole (PPX) Dose | mean Pramipexole (PPX) dose | pre-treatment and after 8-12 weeks | 
| Clinical Global Impressions (CGI) | Clinical Global Impression (CGI) scale at final visit | 8-12 weeks | 
| Patients Global Impressions (PGI) | 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. | 8-12 weeks |