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

September 12, 2005
January 17, 2008
March 2004
September 2004   (final data collection date for primary outcome measure)
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 ]
The primary outcome will be the reduction from baseline in IBZM striatal uptake during a 6-8 hour assessment period after treatment.
Complete list of historical versions of study NCT00200447 on ClinicalTrials.gov Archive Site
Secondary Measures include: Putamen and caudate uptake over time, UPDRS scores, and Pharmacokinetic analysis. [ Time Frame: 6-8hrs ] [ Designated as safety issue: No ]
Secondary Measures include: Putamen and caudate uptake over time, UPDRS scores, and Pharmacokinetic analysis.
Not Provided
Not Provided
 
An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)
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)

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: carbidopa/l-dopa
  • Drug: carbidopa/l-dopa/entacapone
  • Drug: Stalevo
  • Procedure: [123I]-IBZM imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
September 2004
September 2004   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00200447
MNI 0011
Not Provided
John Seibyl M.D., molecular NeuroImaging
Molecular NeuroImaging
Not Provided
Principal Investigator: John P Seibyl, MD Molecular NeuroImaging
Molecular NeuroImaging
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP