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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231294
• Other study ID #: 248.511
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: September 2, 2014
• Start date: July 2000

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1464
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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	Change in Parkinson signs and symptoms by means of a 4-point rating scale		up to 6 weeks	No
Primary	Occurrence of tremor (rest and postural) by means of a 4-point rating scale	Short Parkinson's Evaluation Scale (SPES)	up to 6 weeks	No
Primary	Change in severity of kinetic tremor assessed by tremor spiral test		up to 6 weeks	No
Primary	Occurrence of depression by means of a 4-point SPES rating scale		up to 6 weeks	No
Primary	Change in severity of depression by means of an 8-point rating scale	Clinical Global Impression (CGI) rating scale	up to 6 weeks	No
Primary	Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)	VAS (10 cm)	up to 6 weeks	No
Primary	Assessment of efficacy by investigator on a 5-point rating scale		after 6 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 6 weeks	No
Secondary	Assessment of tolerability by investigator on a 5-point scale		after 6 weeks	No
Secondary	Assessment of tolerability by patient on a 5-point scale		after 6 weeks	No

External Links

•   Link