Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Sifrol®

• Registration Number: NCT02231255
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2002-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-04
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1216

Inclusion Criteria

• Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®

Exclusion Criteria

• Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic Parkinson's disease patients	Sifrol®	-

Primary Outcome Measures

Name	Time	Method
Reason for switch of therapy and reason for using Sifrol®	up to 8 weeks	questionnaire
Type of switch (abrupt or overlapping)	up to 8 weeks
Changes in motor function by means of 5-points rating scale	up to 8 weeks	Short Parkinson's Evaluation Scale (SPES)
Changes in psychopathological memory disturbances by means of 5- point rating scale	up to 8 weeks	Short Parkinson's Evaluation Scale (SPES)
Changes in psychopathological thought disorder disturbances by means of 5- point rating scale	up to 8 weeks	SPES score
Changes in psychopathological depression disturbances by means of 5- point rating scale	up to 8 weeks	SPES score
Changes of mood on seven visual analogue scales (VASs)	up to 8 weeks	assessed by patient
Equivalent doses of Sifrol®	after 8 weeks	compared to previous treatment dosing, based on global clinical impression
Global assessment of efficacy by investigator on a 5-point rating scale	after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse drug reactions	up to 8 weeks
Assessment of tolerability by investigator on a 5-point rating scale	after 8 weeks