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Sponsors and Collaborators: |
Institute for Neurodegenerative Disorders Pfizer GE Healthcare |
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Information provided by: | Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00129181 |
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.
Condition | Intervention |
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Parkinson Disease Parkinsonian Syndrome |
Drug: cabergoline Drug: carbidopa/levodopa Procedure: DATscan and SPECT imaging |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Investigator), 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 |
Enrollment: | 30 |
Study Start Date: | January 2005 |
Study Completion Date: | January 2007 |
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 After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Department of Neurology, Innsbruck Medical University | |
Innsbruck, Austria, 6020 | |
Neurological Department, Wilhelminenspital | |
Vienna, Austria, 1160 | |
Germany | |
Ambulanz für Bewegungsstörungen, Neurologische Poliklinik | |
München, Germany, 81377 | |
Dept. of Neurology, University of Leipzig | |
Leipzig, Germany, 04103 | |
Dept. of Neurology Marburg, Phillips-Univ. | |
Marburg, Germany, 35039 | |
Italy | |
Parkinson Institute Milan | |
Milan, Italy | |
University of Catania-Department of Neurosciences | |
Catania, Italy, 95123 | |
Department of Neurological Sciences-University of Napoli | |
Naples, Italy, 80131 | |
Spain | |
Hospital General Universitario Gregorio Marañón | |
Madrid, Spain, 28007 |
Principal Investigator: | Kenneth L Marek, MD | The Institute for Neurodegenerative Disorders |
Principal Investigator: | John P Seibyl, MD | The Institute for Neurodegenerative Disorders |
Study ID Numbers: | AMAD001 |
Study First Received: | August 9, 2005 |
Last Updated: | November 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00129181 |
Health Authority: | Italy: The Italian Medicines Agency |
parkinson brain imaging diagnosis |
Levodopa Ganglion Cysts Basal Ganglia Diseases Carbidopa Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dopamine Parkinson Disease Movement Disorders Sinemet Parkinsonian Disorders Cabergoline |
Neurotransmitter Agents Disease Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic |
Antiparkinson Agents Enzyme Inhibitors Dopamine Agonists Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Dopamine Agents Central Nervous System Agents |