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OpenTrials
Completed

NCT Number: NCT02248181

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

Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.

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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

  • Diagnosis of early stage idiopathic Parkinson's Disease
  • No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d

Exclusion criteria

  • Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

Treatment and study plan

Pramipexole

Drug

Other names: Sifrol®

Primary outcomes

  1. Change in dosing details of Pramipexole

    Time frame: up to 21 months

  2. Occurrence and clinical course of Parkinson Disease (PD) motor symptoms

    Time frame: up to 21 months

Secondary outcomes

  1. Assessment of Kinetic Tremor

    Time frame: up to 21 months

    Spiral test with at least five rotations from the centre to the edge in blinded fashion

  2. Change in dosing details of L-Dopa

    Time frame: up to 21 months

  3. Global Assessment of tolerability by investigator on 4-point scale

    Time frame: after 21 months

  4. Global assessment of efficacy by investigator on a 4-point scale

    Time frame: after 21 months

  5. Number of patients with adverse drug reactions

    Time frame: up to 21 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease

Important dates

Study start
2004
Primary completion
2005
First posted
Sep 25, 2014
Registry last updated
Sep 25, 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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