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

NCT ID: NCT01950468

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NAV5001

Group Type: EXPERIMENTAL

NAV5001

Intervention Type: DRUG

A single intravenous dose of 8.0 ± 1.0 mCi

DaTscan

Group Type: ACTIVE_COMPARATOR

DaTscan

Intervention Type: DRUG

A single intravenous dose of 3 to 5 mCi

Interventions

NAV5001

A single intravenous dose of 8.0 ± 1.0 mCi

Intervention Type: DRUG

DaTscan

A single intravenous dose of 3 to 5 mCi

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navidea Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelia Reininger, M.D. Ph.D.

Role: STUDY_DIRECTOR

Navidea Biopharmaceuticals

Locations

Xenoscience, Inc.

Phoenix, Arizona, United States

Compass Research

Orlando, Florida, United States

Countries

United States

Other Identifiers

NAV5-02

Identifier Type: -

Identifier Source: org_study_id