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
- Registration Number
- NCT01950468
- Lead Sponsor
- Navidea Biopharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NAV5001 NAV5001 - DaTscan DaTscan -
- Primary Outcome Measures
Name Time Method The incidence of Parkinson' Syndrome based on the on-site neurologist assessment Baseline 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
- Secondary Outcome Measures
Name Time Method Incidence of adverse events post baseline 1 year 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
Trial Locations
- Locations (2)
Compass Research
🇺🇸Orlando, Florida, United States
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States