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

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Pramipexole Extended Release

• Registration Number: NCT01097421
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Primary Completion: 2011-09
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-10-25
• Results First Posted: 2012-11-26
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with parkinsons disease	Pramipexole Extended Release	-

Primary Outcome Measures

Name	Time	Method
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment	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	8-12 weeks	Points on Morisky scale

Secondary Outcome Measures

Name	Time	Method
Patient Preference	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	8-12 weeks	Some patients had not related AEs as well as related AEs.
Pramipexole (PPX) Dose	pre-treatment and after 8-12 weeks	mean Pramipexole (PPX) dose
Clinical Global Impressions (CGI)	8-12 weeks	Clinical Global Impression (CGI) scale at final visit
Patients Global Impressions (PGI)	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.