Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes



Status:Terminated
Conditions:Parkinsons Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - Any
Updated:10/7/2018
Start Date:November 2013
End Date:January 2018

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This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess
the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of
parkinsonian syndromes from non-parkinsonian tremor.


Inclusion Criteria:

- Subject has provided written informed consent before the initiation of any study
related procedures and continues to give willing consent for participation

- Age ≥ 40 years

- Have had upper extremity tremor for < 3 years duration, regardless of presumed
diagnosis or etiology

- Have a UPDRS part III score upon entry of ≤ 16

Exclusion Criteria:

- Any clinically significant or unstable physical or psychological illness based on
medical history or physical examination at screening, as determined by the
investigator

- Structural brain abnormality affecting the entire brain (e.g., normal pressure
hydrocephalus) or the striatum (e.g., local tumor or stroke)

- Any clinically significant abnormal laboratory results obtained at screening and as
determined by the investigator

- Any clinically significant abnormal electrocardiogram (ECG) results obtained at
screening and as determined by the investigator

- Any history of drug, narcotic, or alcohol abuse within 2 years before the date of
informed consent, as defined by the Diagnostic and Statistical Manual of the American
Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric
Association, 1994])

- Positive urine drug screen for opiates, cocaine, or amphetamines at screening

- Positive pregnancy test before imaging

- Participation in an investigational drug or device clinical trial within 30 days
before the date of informed consent

- Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan,
DOPASCAN)

- Any exposure to radiopharmaceuticals within 30 days before the date of informed
consent

- Breast-feeding

- Inability to lie supine for 1 hour

- Any thyroid disease other than adequately treated hypothyroidism

- Known sensitivity or allergy to iodine or iodine containing products

- Treatment within the 30 days before the date of imaging with amoxapine, amphetamine,
benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine,
methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and
sertraline, paroxetine, or citalopram.
We found this trial at
2
sites
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Phoenix, Arizona 85004
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