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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231255
• Other study ID #: 248.517
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: September 16, 2014
• Start date: February 2002

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1216
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Sifrol®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reason for switch of therapy and reason for using Sifrol®	questionnaire	up to 8 weeks	No
Primary	Type of switch (abrupt or overlapping)		up to 8 weeks	No
Primary	Changes in motor function by means of 5-points rating scale	Short Parkinson's Evaluation Scale (SPES)	up to 8 weeks	No
Primary	Changes in psychopathological memory disturbances by means of 5- point rating scale	Short Parkinson's Evaluation Scale (SPES)	up to 8 weeks	No
Primary	Changes in psychopathological thought disorder disturbances by means of 5- point rating scale	SPES score	up to 8 weeks	No
Primary	Changes in psychopathological depression disturbances by means of 5- point rating scale	SPES score	up to 8 weeks	No
Primary	Changes of mood on seven visual analogue scales (VASs)	assessed by patient	up to 8 weeks	No
Primary	Equivalent doses of Sifrol®	compared to previous treatment dosing, based on global clinical impression	after 8 weeks	No
Primary	Global assessment of efficacy by investigator on a 5-point rating scale		after 8 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 8 weeks	No
Secondary	Assessment of tolerability by investigator on a 5-point rating scale		after 8 weeks	No

External Links

•   Link