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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02231294

Enrollment

1464

Registered

2014-09-04

Start date

2000-07-31

Completion date

Unknown

Last updated

2014-09-04

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 SIFROL® on tremor and depression as well as its tolerability 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 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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of efficacy by investigator on a 5-point rating scale	after 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	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)
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	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	—

Secondary

Measure	Time frame
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
Number of patients with adverse drug reactions	up to 6 weeks

Outcome results

None listed

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