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Completed

NCT Number: NCT02231255

Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® 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 who are planned to undergo a switch from another dopamine agonist to Sifrol®

Exclusion criteria

  • Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

Treatment and study plan

Sifrol®

Drug

Primary outcomes

  1. Reason for switch of therapy and reason for using Sifrol®

    Time frame: up to 8 weeks

    questionnaire

  2. Type of switch (abrupt or overlapping)

    Time frame: up to 8 weeks

  3. Changes in motor function by means of 5-points rating scale

    Time frame: up to 8 weeks

    Short Parkinson's Evaluation Scale (SPES)

  4. Changes in psychopathological memory disturbances by means of 5- point rating scale

    Time frame: up to 8 weeks

    Short Parkinson's Evaluation Scale (SPES)

  5. Changes in psychopathological thought disorder disturbances by means of 5- point rating scale

    Time frame: up to 8 weeks

    SPES score

  6. Changes in psychopathological depression disturbances by means of 5- point rating scale

    Time frame: up to 8 weeks

    SPES score

  7. Changes of mood on seven visual analogue scales (VASs)

    Time frame: up to 8 weeks

    assessed by patient

  8. Equivalent doses of Sifrol®

    Time frame: after 8 weeks

    compared to previous treatment dosing, based on global clinical impression

  9. Global assessment of efficacy by investigator on a 5-point rating scale

    Time frame: after 8 weeks

Secondary outcomes

  1. Number of patients with adverse drug reactions

    Time frame: up to 8 weeks

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

    Time frame: after 8 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Important dates

Study start
2002
Primary completion
2002
First posted
Sep 4, 2014
Registry last updated
Sep 17, 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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