Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950455
Recruitment Status : Terminated (The entire drug development program for this molecule was sold to another company.)
First Posted : September 25, 2013
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Parkinson's Syndrome Drug: NAV5001 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
Study Start Date : November 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NAV5001 Drug: NAV5001
A single intravenous dose of 8.0 ± 1.0 mCi




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

Secondary Outcome Measures :
  1. The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months [ Time Frame: 6 months ]
  2. The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year [ Time Frame: 1 Year ]
  3. Incidence of adverse events post baseline [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950455


Locations
Layout table for location information
United States, Arizona
Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
Layout table for investigator information
Study Director: Cornelia Reininger, M.D. Ph.D. Navidea Biopharmaceuticals

Layout table for additonal information
Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01950455    
Other Study ID Numbers: NAV5-01
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: September 2016
Keywords provided by Navidea Biopharmaceuticals:
Parkinson's Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Syndrome
Disease
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases