NCT02248207

Brief Summary

Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,293

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

January 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

10 months

First QC Date

September 22, 2014

Last Update Submit

September 22, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • Global Assessment of efficacy by investigator on a 4-point scale

    after 8 weeks

  • Change from Baseline in actual Parkinson symptoms

    Baseline, after 8 weeks

  • Global Assessment of tolerability by investigator on a 4-point scale

    after 8 weeks

Secondary Outcomes (1)

  • Number of patients with adverse drug reactions

    up to 8 weeks

Study Arms (1)

Parkinson Disease patients

Drug: Pramipexole

Interventions

PramipexoleDRUG
Also known as: Sifrol®
Parkinson Disease patients

Eligibility Criteria

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

Patients with Parkinson's disease recruited at specialist neurologist (private practices and clinics)

You may qualify if:

  • Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study

You may not qualify if:

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

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 22, 2014

First Posted

September 25, 2014

Study Start

January 1, 2003

Primary Completion

November 1, 2003

Last Updated

September 25, 2014

Record last verified: 2014-09