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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson's Syndrome
• Intervention / Treatment: Drug: NAV5001; Drug: DaTscan

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience, Inc.
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAV5001	Drug: NAV5001; A single intravenous dose of 8.0 ± 1.0 mCi
Active Comparator: DaTscan	Drug: DaTscan; A single intravenous dose of 3 to 5 mCi

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
The incidence of positve DaTscan SPECT brain scans	Baseline

Collaborators and Investigators

• Sponsor: Navidea Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson's Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Syndrome; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: NAV5-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No