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Completed

NCT Number: NCT02231294

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sifrol®

Drug

Primary outcomes

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

    Time frame: up to 6 weeks

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

    Time frame: up to 6 weeks

    Short Parkinson's Evaluation Scale (SPES)

  3. Change in severity of kinetic tremor assessed by tremor spiral test

    Time frame: up to 6 weeks

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

    Time frame: up to 6 weeks

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

    Time frame: up to 6 weeks

    Clinical Global Impression (CGI) rating scale

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

    Time frame: up to 6 weeks

    VAS (10 cm)

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

    Time frame: after 6 weeks

Secondary outcomes

  1. Number of patients with adverse drug reactions

    Time frame: up to 6 weeks

  2. Assessment of tolerability by investigator on a 5-point scale

    Time frame: after 6 weeks

  3. Assessment of tolerability by patient on a 5-point scale

    Time frame: after 6 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2002
First posted
Sep 4, 2014
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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