Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00096720
First received: November 12, 2004
Last updated: September 28, 2010
Last verified: May 2007
  Purpose

Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.


Condition Intervention Phase
Parkinson Disease
Parkinsonian Syndrome
Drug: levodopa
Drug: Mirapex (pramipexole)
Procedure: [123I]ß-CIT and SPECT imaging
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Change in outcomes from scan 1 to scan 2

Secondary Outcome Measures:
  • Change in outcomes from scan 2 to scan 3

Enrollment: 112
Study Start Date: February 2004
Study Completion Date: May 2007
Detailed Description:

Brain imaging will be conducted three times during this study. Study participants will travel to IND for [123I]ß-CIT and SPECT imaging (scan 1). Subjects will be randomized to no treatment, treatment with either levodopa, or treatment with Mirapex and undergo treatment for a period of 12 weeks. Subjects will return to IND for [123I]ß-CIT and SPECT imaging (scan 2) after 12 weeks of treatment and withdraw from the medication following the scan. Eight to 12 weeks after medication withdrawal, a final [123I]ß-CIT and SPECT imaging study (scan 3) will be performed at IND. The imaging outcome, striatal uptake of [123I]ß-CIT, from scan 1 (untreated) and scan 2 (treated with levodopa or pramipexole) will be compared to determine if there is a significant change in the uptake of the marker that may be attributed to levodopa or pramipexole treatment. In addition, scan 3 will be compared to scan 2 to determine the duration and reversibility of any regulatory effect that occurs. The subjects will be randomized, but not blinded to study drug assignment. The imaging technologist and all imaging analyses will be performed by investigators blinded to study drug assignment.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30 years or older at time of Parkinson Disease (PD) diagnosis
  • clinical diagnosis of PD of equal to or less than 7.5 years
  • Normal laboratory screening

Exclusion Criteria:

  • Participant is pregnant
  • Participant has atypical or drug induced PD
  • Participant has significant dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096720

Locations
United States, California
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
United States, Colorado
Colorado Neurology, PC
Englewood, Colorado, United States, 80113
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida Movement Disorders Center
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
RUSH University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, New York
Parkinson's Disease and Movement Disorders Center of Albany Medical College
Albany, New York, United States, 12205
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
NeuroHealth, Inc.
Warwick, Rhode Island, United States, 02886
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Boehringer Ingelheim
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
  More Information

Publications:
Parkinson Study Group. Does levodopa slow or hasten the rate of progression of Parkinson's disease? The results of the ELLDOPA trial. Neurology 2003; 60(5) Suppl1: A80-A81.

Responsible Party: Danna Jennings M.D., Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00096720     History of Changes
Other Study ID Numbers: INSPECT
Study First Received: November 12, 2004
Last Updated: September 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
parkinson
brain imaging
diagnosis

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Pramipexole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Protective Agents
Dopamine Agonists

ClinicalTrials.gov processed this record on September 22, 2014