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

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navidea Biopharmaceuticals

Criteria

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.