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

Navidea Biopharmaceuticals

Status and phase

Withdrawn

Phase 3

Conditions

Parkinson's Syndrome

Treatments

Drug: NAV5001

Drug: DaTscan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01950468

NAV5-02

Details and patient eligibility

About

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.