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Completed

NCT Number: NCT02236728

Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole

The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population).

The secondary objectives were:

* Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease. * Evaluate the reasons for choosing pramipexole as treatment. * Identify the patient profiles determining the choice of dose of pramipexole prescribed

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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 suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation

Exclusion criteria

  • Patient refusing to take part
  • Patient taking part in a clinical trial

Treatment and study plan

Pramipexole

Drug

Other names: (Sifrol®)

Primary outcomes

  1. Assessment of Patient's demographic characteristics

    Time frame: 9 months

  2. Assessment of Parkinson's disease characteristics

    Time frame: 9 months

Secondary outcomes

  1. Assessment of Severity of the Parkinson Disease (PD)

    Time frame: 9 months

    (levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase)

  2. Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores

    Time frame: 9 months

  3. Description of the actual treatments of PD

    Time frame: 9 months

  4. Evaluation for reasons for choosing pramipexole as treatment

    Time frame: 9 months

  5. Assessment of Treatment history

    Time frame: 9 months

    3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment

  6. Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D

    Time frame: 9 months

  7. Number of patients with adverse events

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)

Important dates

Study start
2008
Primary completion
2008
First posted
Sep 11, 2014
Registry last updated
Sep 11, 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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