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

N

Navidea Biopharmaceuticals

Status and phase

Terminated
Phase 3

Conditions

Parkinson's Syndrome

Treatments

Drug: NAV5001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01950455
NAV5-01

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

NAV5001
Experimental group
Treatment:
Drug: NAV5001

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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