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

Phase 3

Terminated

• Conditions: Parkinson's Syndrome
• Interventions: Drug: NAV5001

• Registration Number: NCT01950455
• Lead Sponsor: Navidea Biopharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-25
• Study Start: 2013-11
• Status Verified: 2016-09
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAV5001	NAV5001	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Xenoscience, Inc.; 🇺🇸 Phoenix, Arizona, United States

Compass Research; 🇺🇸 Orlando, Florida, United States