NCT02248220

Brief Summary

Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability

Trial Health

100
On Track

Trial Health Score

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

Enrollment
657

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

October 1, 1998

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1999

Completed
15 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 year

First QC Date

September 22, 2014

Last Update Submit

September 22, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Change in cumulative daily doses of Sifrol®

    Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

    up to 8 weeks

  • Changes in cumulative daily doses of L-dopa

    Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

    up to 8 weeks

Secondary Outcomes (9)

  • Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score

    Baseline, after 8 weeks

  • Change from Baseline in SPES subscales

    Baseline, after 8 weeks

  • Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score

    Baseline, after 8 weeks

  • Change from Baseline in Tremor Impact Scale (TIS-D) total score

    Baseline, after 8 weeks

  • Change from Baseline in global Parkinson's Disease (PD) symptoms

    Baseline, after 8 weeks

  • +4 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

Patients with advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals

You may qualify if:

  • Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated

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

October 1, 1998

Primary Completion

October 1, 1999

Last Updated

September 25, 2014

Record last verified: 2014-09