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

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Sifrol®

• Study Type: Observational
• Enrollment (Actual): 1464

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Idiopathic Parkinson's Disease Patients	Drug: Sifrol®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): January 1, 2002

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): September 4, 2014
• Last Update Submitted That Met QC Criteria: September 2, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dopamine Agonists; Dopamine Agents; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole
• Other Study ID Numbers: 248.511