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Wolff-Parkinson-White Syndrome |
WPW |
Clinical Trial: Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Parkinson Disease Parkinsonian Syndrome | Drug: levodopa Drug: Mirapex (pramipexole) Procedure: [123I]ß-CIT and SPECT imaging | Phase II |
MedlinePlus related topics: Brain Diseases; Movement Disorders; Parkinson's Disease
Genetics Home Reference related topics: Parkinson disease
Study Type: Interventional
Study Design: Diagnostic, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Investigating Effects of Short-term Treatment with Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson’s
Secondary Outcomes: Change in outcomes from scan 2 to scan 3
Expected Total Enrollment: 180
Study start: February 2004; Expected completion: December 2008
Last follow-up: January 2008; Data entry closure: April 2008
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 above, Genders Eligible for Study: Both
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
Location and Contact Information
Connecticut
Institute for Neurodegenerative Disorders, New Haven, Connecticut, 06510, United States; Recruiting
Debbie Ruotolo 203-401-4300 druotolo@indd.org
Rowena Tabamo, MD, Principal Investigator
Florida
University of Florida Movement Disorders Center, Gainesville, Florida, 32610, United States; Recruiting
Carlee Jones 352-392-3491
Hubert Fernandez, MD, Principal Investigator
Illinois
Northwestern University, Chicago, Illinois, 60611, United States; Not yet recruiting
Tanya Simuni, Principal Investigator
Kansas
The University of Kansas Medical Center, Parkinson and Movement Disorder Center, Kansas City, Kansas, 66160, United States; Recruiting
Tamara Gales 913-588-5250 tgales@kumc.edu
Rajesh Pahwa, MD, Principal Investigator
Massachusetts
Boston University Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Cathi Thomas 617-638-7737 neurocat@bu.edu
Marie Saint-Hilaire, MD, Principal Investigator
Lahey Clinic Medical Center, Burlington, Massachusetts, 01805, United States; Not yet recruiting
Diana Apetauerova, MD, Principal Investigator
New York
Parkinson's Disease and Movement Disorders Center of Albany Medical College, Albany, New York, 12205, United States; Recruiting
Sharon Evans 518-452-0914 evanss@mail.amc.edu
Eric Molho, MD, Principal Investigator
North Carolina
Duke University, Durham, North Carolina, 27705, United States; Not yet recruiting
Mark Stacy, MD, Principal Investigator
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Suzanne Reichwein 215-829-8560 sreichwein@pahosp.com
Andrew Siderowf, MD, Principal Investigator
Rhode Island
Brown University/Memorial Hospital of Rhode Island, Providence, Rhode Island, 02860, United States; Recruiting
Joseph Friedman, MD, Principal Investigator
Tennessee
University of Tennessee Health Science Center, Memphis, Tennessee, 38163, United States; Not yet recruiting
Brenda Pfeiffer, RN 901-271-5966 bpfeiffer@utmem.edu
Ronald F. Pfeiffer, MD, Principal Investigator
Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
More Information
Publications
Ahlskog JE. Slowing Parkinson's disease progression: recent dopamine agonist trials. Neurology. 2003 Feb 11;60(3):381-9. Review.
Ahlskog JE, Uitti RJ, O'Connor MK, Maraganore DM, Matsumoto JY, Stark KF, Turk MF, Burnett OL. The effect of dopamine agonist therapy on dopamine transporter imaging in Parkinson's disease. Mov Disord. 1999 Nov;14(6):940-6.
Guttman M, Stewart D, Hussey D, Wilson A, Houle S, Kish S. Influence of L-dopa and pramipexole on striatal dopamine transporter in early PD. Neurology. 2001 Jun 12;56(11):1559-64.
Guttman M, Stewart D, Hussey D, Wilson A, Houle S, Kish S. Influence of L-dopa and pramipexole on striatal dopamine transporter in early PD. Neurology. 2001 Jun 12;56(11):1559-64.
Innis RB, Marek KL, Sheff K, Zoghbi S, Castronuovo J, Feigin A, Seibyl JP. Effect of treatment with L-dopa/carbidopa or L-selegiline on striatal dopamine transporter SPECT imaging with [123I]beta-CIT. Mov Disord. 1999 May;14(3):436-42.
Little KY, Gorebig J, Carroll FI, Mapili J, Meador-Woodruff JH. Lack of dopamine receptor agonists effect on striatal dopamine transporter binding sites. Brain Res. 1996 Dec 2;742(1-2):313-6.
Marek K, Innis R, van Dyck C, Fussell B, Early M, Eberly S, Oakes D, Seibyl J. [123I]beta-CIT SPECT imaging assessment of the rate of Parkinson's disease progression. Neurology. 2001 Dec 11;57(11):2089-94.
Morrish PK, Rakshi JS, Bailey DL, Sawle GV, Brooks DJ. Measuring the rate of progression and estimating the preclinical period of Parkinson's disease with [18F]dopa PET. J Neurol Neurosurg Psychiatry. 1998 Mar;64(3):314-9.
Nurmi E, Bergman J, Eskola O, Solin O, Hinkka SM, Sonninen P, Rinne JO. Reproducibility and effect of levodopa on dopamine transporter function measurements: a [18F]CFT PET study. J Cereb Blood Flow Metab. 2000 Nov;20(11):1604-9.
Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. JAMA. 2002 Apr 3;287(13):1653-61.
Rioux L, Frohna PA, Joyce JN, Schneider JS. The effects of chronic levodopa treatment on pre- and postsynaptic markers of dopaminergic function in striatum of parkinsonian monkeys. Mov Disord. 1997 Mar;12(2):148-58.
Whone AL, Watts RL, Stoessl AJ, Davis M, Reske S, Nahmias C, Lang AE, Rascol O, Ribeiro MJ, Remy P, Poewe WH, Hauser RA, Brooks DJ; REAL-PET Study Group. Slower progression of Parkinson's disease with ropinirole versus levodopa: The REAL-PET study. Ann Neurol. 2003 Jul;54(1):93-101.
Wooten GF. Agonists vs levodopa in PD: the thrilla of whitha. Neurology. 2003 Feb 11;60(3):360-2. No abstract available.
Record last reviewed: November 2004
Last Updated: November 15, 2004
Record first received: November 12, 2004
ClinicalTrials.gov Identifier: NCT00096720
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Wolff-Parkinson-White Syndrome (Cleveland Clinic)
- Wolff-Parkinson-White syndrome (Google Health)
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