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 scaleOccurrence 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 reactionsAssessment 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
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