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

This study has been completed.
Sponsor:
Information provided by:
Molecular NeuroImaging
ClinicalTrials.gov Identifier:
NCT00200447
First received: September 12, 2005
Last updated: January 17, 2008
Last verified: January 2008
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Molecular NeuroImaging:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Measures include: Putamen and caudate uptake over time, UPDRS scores, and Pharmacokinetic analysis. [ Time Frame: 6-8hrs ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: March 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200447

Sponsors and Collaborators
Molecular NeuroImaging
Investigators
Principal Investigator: John P Seibyl, MD Molecular NeuroImaging
  More Information

Publications:

Responsible Party: John Seibyl M.D., molecular NeuroImaging
ClinicalTrials.gov Identifier: NCT00200447     History of Changes
Other Study ID Numbers: MNI 0011
Study First Received: September 12, 2005
Last Updated: January 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Molecular NeuroImaging:
Parkinson
brain imaging

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Entacapone
 Dihydroxyphenylalanine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013