NCT02236728

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 10, 2014

Last Update Submit

September 10, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Assessment of Patient's demographic characteristics

    9 months

  • Assessment of Parkinson's disease characteristics

    9 months

Secondary Outcomes (7)

  • Assessment of Severity of the Parkinson Disease (PD)

    9 months

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

    9 months

  • Description of the actual treatments of PD

    9 months

  • Evaluation for reasons for choosing pramipexole as treatment

    9 months

  • Assessment of Treatment history

    9 months

  • +2 more secondary outcomes

Study Arms (1)

Parkinson's disease patients

Drug: Pramipexole

Interventions

PramipexoleDRUG
Also known as: (Sifrol®)
Parkinson's disease patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic 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 10, 2014

First Posted

September 11, 2014

Study Start

February 1, 2008

Primary Completion

November 1, 2008

Last Updated

September 11, 2014

Record last verified: 2014-09