NCT02248168

Brief Summary

The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.

  • Unexpected adverse events (especially, serious adverse events (SAEs))
  • To find out the status of incidence of adverse events under actual practice
  • Factors on the safety profile
  • Factors on the efficacy profile

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,449

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
7.7 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

4.8 years

First QC Date

September 22, 2014

Last Update Submit

September 22, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Assessment of Unified Parkinson's disease Rating Scale (UPDRS)

    Tremor at rest, Rigidity, Body bradykinesia and hypokinesia

    up to 4 weeks

Secondary Outcomes (2)

  • Number of patients with adverse events

    up to 4 weeks

  • Global Assessment of efficacy by investigator on 3-point scale

    after 4 weeks

Study Arms (1)

Idiopathic Parkinson's disease patients

Drug: Pramipexole

Interventions

PramipexoleDRUG
Also known as: Mirapex®
Idiopathic 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

Patients with idiopathic Parkinson's disease

You may qualify if:

  • Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping

You may not qualify if:

  • Following patients are contraindicated.
  • Patients who are hypersensitive to MIRAPEX or its ingredients
  • Refer to the insert paper for other contraindication.
  • Following patients should be carefully administered.
  • Patient with renal impairment
  • Refer to the insert paper for other precaution.

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

March 1, 2002

Primary Completion

January 1, 2007

Last Updated

September 25, 2014

Record last verified: 2014-09