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An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200447
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 21, 2008
Information provided by:
Molecular NeuroImaging

Brief Summary:
This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: carbidopa/l-dopa Drug: carbidopa/l-dopa/entacapone Drug: Stalevo Procedure: [123I]-IBZM imaging Phase 2

Detailed Description:
This is a pilot evaluation of dopaminergic function in PD using a bolus plus constant infusion protocol with [123I]-IBZM and SPECT to evaluate the potential for carbidopa/l-dopa alone or carbidopa/l-dopa/entacapone to produce displacement of striatal radioactivity for assessment of intrasynaptic dopamine. We will assess the feasibility of this paradigm for detecting l-dopa effects on the SPECT signal in subjects with PD with disease duration of greater than 4yrs and with a stable response to L-dopa. Each subject will undergo three [123I]-IBZM studies separated by 1-2 weeks. Subjects will be off medication for at least 12 h prior to study For each of the three scan days patients will receive a constant intravenous infusion of [123I]-IBZM over 4-5 hours to establish an equilibrium binding condition of the radiotracer at striatal D2/D3 receptors. Three baseline SPECT acquisitions will be obtained prior to medication dosing to establish a stable baseline. At approximately 5 h after the initiation of the infusion subjects will receive a single oral dose of either carbidopa/levodopa (37.5mg/150mg or 50mg/250mg), or carbidopa/levodopa/entacapone (either 37.5mg/150mg/200mg- STALEVO or 50/250mg/200mg).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)
Study Start Date : March 2004
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Carbidopa

Primary Outcome Measures :
  1. The primary outcome will be the reduction from baseline in IBZM striatal uptake during a 6-8 hour assessment period after treatment. [ Time Frame: 6-8hrs ]

Secondary Outcome Measures :
  1. Secondary Measures include: Putamen and caudate uptake over time, UPDRS scores, and Pharmacokinetic analysis. [ Time Frame: 6-8hrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main inclusion criteria:

  • The patient is aged 30 years or older.
  • Written informed consent is obtained.
  • Patients have a diagnosis of idiopathic Parkinson's disease.
  • Hoehn and Yahr stages for patients are I-III.
  • Patients have a diagnosis> 4 yrs prior to screening
  • Patients are treated with carbidopa/levodopa with > 300 mg levodopa.

Main exclusion criteria:

  • The patient has atypical or drug-induced Parkinson's disease.
  • The patient has dementia (MMSE 24).
  • The patient has a clinically significant clinical laboratory values, and/or medical or psychiatric illness.
  • The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
  • The patient has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
  • The patient has been treated with a dopamine agonist within the past 30 days.
  • Concomitant treatment with Monoamine Oxidase (MAO)-inhibitors (except selegiline <10 mg/day) within 30 days prior to the screening visit
  • Patient has a history of iodine allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200447

Sponsors and Collaborators
Molecular NeuroImaging
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Principal Investigator: John P Seibyl, MD Molecular NeuroImaging
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Responsible Party: John Seibyl M.D., molecular NeuroImaging Identifier: NCT00200447    
Other Study ID Numbers: MNI 0011
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 21, 2008
Last Verified: January 2008
Keywords provided by Molecular NeuroImaging:
brain imaging
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors