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

Boehringer Ingelheim1,464 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,464

Conditions

Parkinson Disease

Interventions

Sifrol®DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Parkinson signs and symptoms by means of a 4-point rating scale

Time frame: up to 6 weeks

Occurrence of tremor (rest and postural) by means of a 4-point rating scale

Short Parkinson's Evaluation Scale (SPES)

Time frame: up to 6 weeks

Change in severity of kinetic tremor assessed by tremor spiral test

Time frame: up to 6 weeks

Occurrence of depression by means of a 4-point SPES rating scale

Time frame: up to 6 weeks

Change in severity of depression by means of an 8-point rating scale

Clinical Global Impression (CGI) rating scale

Time frame: up to 6 weeks

Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)

VAS (10 cm)

Time frame: up to 6 weeks

Assessment of efficacy by investigator on a 5-point rating scale

Time frame: after 6 weeks

Secondary Outcomes

Number of patients with adverse drug reactions

Time frame: up to 6 weeks

Assessment of tolerability by investigator on a 5-point scale

Time frame: after 6 weeks

Assessment of tolerability by patient on a 5-point scale

Time frame: after 6 weeks

Data from ClinicalTrials.gov

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