NCT02248181

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
442

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, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
8.8 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

1.8 years

First QC Date

September 22, 2014

Last Update Submit

September 22, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Change in dosing details of Pramipexole

    up to 21 months

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

    up to 21 months

Secondary Outcomes (5)

  • Assessment of Kinetic Tremor

    up to 21 months

  • Change in dosing details of L-Dopa

    up to 21 months

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

    after 21 months

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

    after 21 months

  • Number of patients with adverse drug reactions

    up to 21 months

Study Arms (1)

Idiopathic PD patients

Drug: Pramipexole

Interventions

PramipexoleDRUG
Also known as: Sifrol®
Idiopathic PD patients

Eligibility Criteria

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

Idiopathic PD patients recruited at office-based neurologists, psychiatrists or physicians in special neurological clinics

You may qualify if:

  • 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

You may not qualify if:

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

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

February 1, 2004

Primary Completion

December 1, 2005

Last Updated

September 25, 2014

Record last verified: 2014-09