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

NCT01950468 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: NAV5-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

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

  Baseline

• 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

Other Outcomes (1)

• The incidence of positve DaTscan SPECT brain scans

  Baseline

Study Arms (2)

NAV5001

EXPERIMENTAL

Drug: NAV5001

DaTscan

ACTIVE COMPARATOR

Drug: DaTscan

Interventions

NAV5001 DRUG

A single intravenous dose of 8.0 ± 1.0 mCi

NAV5001

DaTscan DRUG

A single intravenous dose of 3 to 5 mCi

DaTscan

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

Interventions

ioflupane

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: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 25, 2013
• Study Start: April 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

US (2)