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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Sifrol® (Drug)

Phase: N/A

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

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

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

Change in severity of kinetic tremor assessed by tremor spiral test

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

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

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

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

Secondary outcome:

Number of patients with adverse drug reactions

Assessment of tolerability by investigator on a 5-point scale

Assessment of tolerability by patient on a 5-point scale

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: July 2000
Last updated: September 2, 2014

Page last updated: August 23, 2015

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