Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

NCT00129181

Last updated date
Study Location
Department of Neurology, Innsbruck Medical University
Innsbruck, , 6020, Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson Disease, Parkinsonian Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The subject is aged 40 years or older.

- Written informed consent is obtained.

- Subjects have a clinical diagnosis of idiopathic Parkinson's disease.

- Hoehn and Yahr stages for subjects are I-II.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- The subject has atypical or drug-induced Parkinson's disease.


- The subject has dementia.


- The subject has clinically significant abnormal laboratory values, and/or clinically
significant or unstable medical or psychiatric illness.


- The subject is pregnant.

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Parkinson Disease, Parkinsonian SyndromeStudy of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease
NCT00129181
  1. Innsbruck,
  2. Vienna,
  3. Leipzig,
  4. Marburg,
  5. München,
  6. Catania,
  7. Milan,
  8. Naples,
  9. Madrid,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease
Official Title  ICMJE A Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's Disease
Brief Summary This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.
Detailed Description This is a multi-center, open-label study of short-term treatment with levodopa or cabergoline on striatal DATscan uptake in early Parkinson's disease. Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Parkinson Disease
  • Parkinsonian Syndrome
Intervention  ICMJE
  • Drug: cabergoline
    Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
  • Drug: carbidopa/levodopa
    Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
  • Procedure: DATscan and SPECT imaging
    Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2007)
30
Original Enrollment  ICMJE
 (submitted: August 9, 2005)
120
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject is aged 40 years or older.
  • Written informed consent is obtained.
  • Subjects have a clinical diagnosis of idiopathic Parkinson's disease.
  • Hoehn and Yahr stages for subjects are I-II.

Exclusion Criteria:

  • The subject has atypical or drug-induced Parkinson's disease.
  • The subject has dementia.
  • The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
  • The subject is pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Italy,   Spain
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00129181
Other Study ID Numbers  ICMJE AMAD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Institute for Neurodegenerative Disorders
Collaborators  ICMJE
  • Pfizer
  • GE Healthcare
Investigators  ICMJE
Principal Investigator:Kenneth L Marek, MDThe Institute for Neurodegenerative Disorders
Principal Investigator:John P Seibyl, MDThe Institute for Neurodegenerative Disorders
PRS Account Institute for Neurodegenerative Disorders
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP