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

Parkinson's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01950468
• Other study ID #: NAV5-02
• Status: Withdrawn
• Phase: Phase 3
• First received: September 23, 2013
• Last updated: September 12, 2017
• Start date: April 2017
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: Navidea Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Syndrome
• Syndrome

Intervention

Drug:
• NAV5001
A single intravenous dose of 8.0 ± 1.0 mCi
• DaTscan
A single intravenous dose of 3 to 5 mCi

Locations

Country	Name	City	State
United States	Compass Research	Orlando	Florida
United States	Xenoscience, Inc.	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Navidea Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of positve DaTscan SPECT brain scans		Baseline
Primary	The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel		One Year
Primary	The incidence of positve [123I]NAV5001 SPECT brain scans		Baseline
Primary	The incidence of Parkinson' Syndrome based on the on-site neurologist assessment		Baseline
Secondary	The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months		6 months
Secondary	The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year		1 Year
Secondary	Incidence of adverse events post baseline		1 year