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

NCT01950455 | Terminated Phase 3

• 1 other identifier: NAV5-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Syndrome

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

NAV5001

EXPERIMENTAL

Drug: NAV5001

Interventions

NAV5001 DRUG

A single intravenous dose of 8.0 ± 1.0 mCi

NAV5001

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead

Study Sites (2)

Xenoscience, Inc.

Phoenix, Arizona, 85004, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Cornelia Reininger, M.D. Ph.D.

  Navidea Biopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 25, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2016-09

Locations

US (2)