The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease

Completed

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

• Registration Number: NCT02231294
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2002-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Last Update Submitted: 2014-09-02
• Study First Posted: 2014-09-04
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1464

Inclusion Criteria

• Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study

Exclusion Criteria

• Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®
• Patients under treatment with neuroleptics should not be observed during this study

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
Occurrence of tremor (rest and postural) by means of a 4-point rating scale	up to 6 weeks	Short Parkinson's Evaluation Scale (SPES)
Change in severity of kinetic tremor assessed by tremor spiral test	up to 6 weeks
Occurrence of depression by means of a 4-point SPES rating scale	up to 6 weeks
Assessment of efficacy by investigator on a 5-point rating scale	after 6 weeks
Change in Parkinson signs and symptoms by means of a 4-point rating scale	up to 6 weeks
Change in severity of depression by means of an 8-point rating scale	up to 6 weeks	Clinical Global Impression (CGI) rating scale
Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)	up to 6 weeks	VAS (10 cm)

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse drug reactions	up to 6 weeks
Assessment of tolerability by investigator on a 5-point scale	after 6 weeks
Assessment of tolerability by patient on a 5-point scale	after 6 weeks