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Wolff-Parkinson-White Syndrome |
WPW |
Clinical Trial: Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects with Parkinson''s Disease
This study is currently recruiting patients.
Verified by Institute for Neurodegenerative Disorders August 2005
|
Purpose
| Condition | Intervention |
|---|---|
| Parkinson Disease Parkinsonian Syndrome | Drug: cabergoline Drug: carbidopa/levodopa Procedure: DATscan and SPECT imaging |
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: 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
Secondary Outcomes: - To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson’s disease.; - To further develop the AMADEUS consortium, a collaboration of clinical-imaging SPECT DAT sites able to obtain data using comparable techniques and transmit imaging to a central analysis site.
Expected Total Enrollment: 120
Study start: January 2005; Expected completion: March 2008
Last follow-up: July 2007; Data entry closure: December 2007
Eligibility
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.
Location and Contact Information
Austria
Department of Neurology, Innsbruck Medical University, Innsbruck, 6020, Austria; Recruiting
Werner Poewe, Principal Investigator
Neurological Department, Wilhelminenspital, Vienna, 1160, Austria; Recruiting
Thomas Brücke, Principal Investigator
Germany
Ambulanz für Bewegungsstörungen, Neurologische Poliklinik, München, 81377, Germany; Recruiting
Kai Bötzel 089-70963690 Kai.Boetzel@med.uni-muenchen.de
Kai Boetzel, Principal Investigator
Dept. of Neurology, University of Leipzig, Leipzig, 04103, Germany; Recruiting
Swen Hesse 49-341-9718000 Swen.Hesse@medizin.uni-leipzig.de
Johannes Schwarz, Principal Investigator
Dept. of Neurology Marburg, Phillips-Univ., Marburg, 35039, Germany; Recruiting
Wolfgang Oertel, Principal Investigator
Italy
Parkinson Institute Milan, Milan, Italy; Recruiting
Alba Bonetti +39-02-57993374 alba@parkinson.it
Paolo Barone, Principal Investigator
University of Catania-Department of Neurosciences, Catania, 95123, Italy; Recruiting
Mario Zappia, MD, Principal Investigator
Department of Neurological Sciences-University of Napoli, Naples, 80131, Italy; Recruiting
Paolo Barone, MD, Principal Investigator
Spain
Hospital Clinic of Barcelona. Neurology Service, Barcelona, 08036, Spain; Recruiting
Eduardo Tolosa, Principal Investigator
Hospital General Universitario Gregorio Marañón, Madrid, 28007, Spain; Recruiting
Francisco Grandas, Principal Investigator
United Kingdom
Royal Free Hospital, Dept. of Neurology, London, NW3 2QG, United Kingdom; Recruiting
James Rakshi, Principal Investigator
Kenneth L Marek, MD, Principal Investigator, The Institute for Neurodegenerative Disorders
John P Seibyl, MD, Principal Investigator, The 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.
Brucke T, Asenbaum S, Pirker W, Djamshidian S, Wenger S, Wober C, Muller C, Podreka I. Measurement of the dopaminergic degeneration in Parkinson''''s disease with [123I] beta-CIT and SPECT. Correlation with clinical findings and comparison with multiple system atrophy and progressive supranuclear palsy. J Neural Transm Suppl. 1997;50:9-24.
Fahn S. Is levodopa toxic? Neurology. 1996 Dec;47(6 Suppl 3):S184-95. Review. No abstract available.
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, Seibyl JP, Scanley BE, Laruelle M, Abi-Dargham A, Wallace E, Baldwin RM, Zea-Ponce Y, Zoghbi S, Wang S, et al. Single photon emission computed tomographic imaging demonstrates loss of striatal dopamine transporters in Parkinson disease. Proc Natl Acad Sci U S A. 1993 Dec 15;90(24):11965-9.
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.
Schapira AH. Dopamine agonists and neuroprotection in Parkinson''''s disease. Eur J Neurol. 2002 Nov;9 Suppl 3:7-14. Review.
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.
Last Updated: August 10, 2005
Record first received: August 9, 2005
ClinicalTrials.gov Identifier: NCT00129181
Health Authority: Italy: The Italian Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Wolff-Parkinson-White Syndrome (Cleveland Clinic)
- Wolff-Parkinson-White syndrome (Google Health)
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