Parkinson's Syndrome
Conditions
Keywords
Parkinson's Disease
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.
Interventions
DRUGNAV5001
A single intravenous dose of 8.0 ± 1.0 mCi
Sponsors
Navidea Biopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel | One Year |
| The incidence of positve [123I]NAV5001 SPECT brain scans | One Year |
| The incidence of Parkinson' Syndrome based on the on-site neurologist assessment | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of adverse events post baseline | 1 year |
Countries
United States
Outcome results
None listed