NCT00666653

Brief Summary

The purpose of this study is to determine whether there is a benefit to giving a dopamine agonist to a patient with Parkinson's disease who is already being treated with levodopa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

July 1, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
Last Updated

April 25, 2008

Status Verified

April 1, 2008

Enrollment Period

3.8 years

First QC Date

April 23, 2008

Last Update Submit

April 24, 2008

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseDopamine AgonistLevodopaPharmacokineticsDyskinesia

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve of motor function based on finger tapping scores

    2 months

Secondary Outcomes (2)

  • Dyskinesia rating score

    2 months

  • Gait performance

    2 months

Interventions

pramipexoleDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30-80
  • Idiopathic PD Hoehn \& Yahr stage 2-4,
  • diagnosed by 2 of the 3 cardinal motor features
  • Fluctuation response to levodopa
  • Dyskinesia
  • No other historical, laboratory or physical signs to suggest an alternate diagnosis
  • No significant dementia, MMSE\>24
  • On oral levodopa therapy

You may not qualify if:

  • dementia
  • psychosis
  • severe anxiety
  • unstable cardiovascular disease
  • uncontrolled hypertension
  • history of cardiac arrhythmias
  • active peptic ulcer disease
  • anemia (HCT\<32%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Brodsky MA, Park BS, Nutt JG. Effects of a dopamine agonist on the pharmacodynamics of levodopa in Parkinson disease. Arch Neurol. 2010 Jan;67(1):27-32. doi: 10.1001/archneurol.2009.287.

    PMID: 20065126DERIVED

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Matthew A Brodsky, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

July 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 25, 2008

Record last verified: 2008-04

Locations

US(1)