A Cross-Over, Multi-Center Trial to Evaluate the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes

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

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

Conditions
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Parkinson's Syndrome

Intervention / Treatment
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* Drug: NAV5001
* Drug: DaTscan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAV5001<br> | Drug: NAV5001<br>* A single intravenous dose of 8.0 ± 1.0 mCi<br>|
| Active Comparator: DaTscan<br> | Drug: DaTscan<br>* A single intravenous dose of 3 to 5 mCi<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel |  | One Year | 
| The incidence of positve [123I]NAV5001 SPECT brain scans |  | Baseline | 
| The incidence of Parkinson' Syndrome based on the on-site neurologist assessment |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months |  | 6 months | 
| The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year |  | 1 Year | 
| Incidence of adverse events post baseline |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease