Clinical trial NCT01950468: 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
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Parkinson's Syndrome
Keywords: Parkinson's Disease
Lead sponsor: Navidea Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel
timeFrame: One Year
measure: The incidence of positve [123I]NAV5001 SPECT brain scans
timeFrame: Baseline
measure: The incidence of Parkinson' Syndrome based on the on-site neurologist assessment
timeFrame: Baseline
Secondary outcomes:
measure: The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months
timeFrame: 6 months
measure: The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year
timeFrame: 1 Year
measure: Incidence of adverse events post baseline
timeFrame: 1 year
Other outcomes:
measure: The incidence of positve DaTscan SPECT brain scans
timeFrame: Baseline
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Orlando
country: United States
facility: Compass Research
state: Florida
Study officials:
affiliation: Navidea Biopharmaceuticals
name: Cornelia Reininger, M.D. Ph.D.
role: STUDY_DIRECTOR
References: