- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200447
An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)
January 17, 2008 updated by: Molecular NeuroImaging
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6-8hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary Measures include: Putamen and caudate uptake over time, UPDRS scores, and Pharmacokinetic analysis.
Time Frame: 6-8hrs
|
6-8hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John P Seibyl, MD, Molecular NeuroImaging
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Castner SA, al-Tikriti MS, Baldwin RM, Seibyl JP, Innis RB, Goldman-Rakic PS. Behavioral changes and [123I]IBZM equilibrium SPECT measurement of amphetamine-induced dopamine release in rhesus monkeys exposed to subchronic amphetamine. Neuropsychopharmacology. 2000 Jan;22(1):4-13. doi: 10.1016/S0893-133X(99)00080-9.
- de la Fuente-Fernandez R, Lu JQ, Sossi V, Jivan S, Schulzer M, Holden JE, Lee CS, Ruth TJ, Calne DB, Stoessl AJ. Biochemical variations in the synaptic level of dopamine precede motor fluctuations in Parkinson's disease: PET evidence of increased dopamine turnover. Ann Neurol. 2001 Mar;49(3):298-303. doi: 10.1002/ana.65.abs.
- Laruelle M, D'Souza CD, Baldwin RM, Abi-Dargham A, Kanes SJ, Fingado CL, Seibyl JP, Zoghbi SS, Bowers MB, Jatlow P, Charney DS, Innis RB. Imaging D2 receptor occupancy by endogenous dopamine in humans. Neuropsychopharmacology. 1997 Sep;17(3):162-74. doi: 10.1016/S0893-133X(97)00043-2.
- Seibyl JP, Woods SW, Zoghbi SS, Baldwin RM, Dey HM, Goddard AW, Zea-Ponce Y, Zubal G, Germine M, Smith EO, et al. Dynamic SPECT imaging of dopamine D2 receptors in human subjects with iodine-123-IBZM. J Nucl Med. 1992 Nov;33(11):1964-71.
- Seibyl JP, Zea-Ponce Y, Brenner L, Baldwin RM, Krystal JH, Offord SJ, Mochoviak S, Charney DS, Hoffer PB, Innis RB. Continuous intravenous infusion of iodine-123-IBZM for SPECT determination of human brain dopamine receptor occupancy by antipsychotic agent RWJ-37796. J Nucl Med. 1996 Jan;37(1):11-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Primary Completion (ACTUAL)
September 1, 2004
Study Completion (ACTUAL)
September 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 20, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 21, 2008
Last Update Submitted That Met QC Criteria
January 17, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Catechol O-Methyltransferase Inhibitors
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
- Dihydroxyphenylalanine
- Entacapone
Other Study ID Numbers
- MNI 0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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