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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02231255

Enrollment

1216

Registered

2014-09-04

Start date

2002-02-28

Completion date

Unknown

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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

Interventions

DRUGSifrol®

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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®

Design outcomes

Primary

Measure	Time frame	Description
Global assessment of efficacy by investigator on a 5-point rating scale	after 8 weeks	—
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
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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026