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

NCT02231294 | Completed

• 1 other identifier: 248.511
• Study Type: observational
• Target: 1,464
• Locations: 0 countries
• Sites: N/A

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (7)

• 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

  Short Parkinson's Evaluation Scale (SPES)

  up to 6 weeks

• Change in severity of kinetic tremor assessed by tremor spiral test

  up to 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

  Clinical Global Impression (CGI) rating scale

  up to 6 weeks

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

  VAS (10 cm)

  up to 6 weeks

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

  after 6 weeks

Secondary Outcomes (3)

• Number of patients with adverse drug reactions

  up to 6 weeks

• 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

Study Arms (1)

Idiopathic Parkinson's Disease Patients

Drug: Sifrol®

Interventions

Sifrol® DRUG

Idiopathic Parkinson's Disease Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: July 1, 2000
• Primary Completion: January 1, 2002
• Last Updated: September 4, 2014

Record last verified: 2014-09