[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205397":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":23,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":11,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":68,"whyStopped":69,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Navidea Biopharmaceuticals","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NAV5001","EXPERIMENTAL",null,[13],"Drug: NAV5001",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","A single intravenous dose of 8.0 ± 1.0 mCi",[9],[20],{"name":21,"affiliation":5,"role":22},"Cornelia Reininger, M.D. Ph.D.","STUDY_DIRECTOR",[24,37],{"facility":25,"status":11,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":11},"Xenoscience, Inc.","Phoenix","Arizona","85004","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-112.07404,33.44838,{"lat":35,"lon":34},{"facility":38,"status":11,"city":39,"state":40,"zip":41,"country":29,"countryCode":30,"cosmosGeoPoint":42,"geoPoint":46,"contacts":11},"Compass Research","Orlando","Florida","32806",{"type":32,"coordinates":43},[44,45],-81.37924,28.53834,{"lat":45,"lon":44},{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100205397","phase-3-evaluation-of-the-diagnostic-efficacy-and-safety-of-123inav5001-as-an-imaging-agent-to-aid-in-the-diagnosis-of-parkinsonian-syndromes-100205397",false,"NCT01950455","Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes","Inclusion Criteria:\n\n* Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation\n* Age ≥ 40 years\n* Have had upper extremity tremor for \\\u003C 3 years duration, regardless of presumed diagnosis or etiology\n* Have a UPDRS part III score upon entry of ≤ 16\n\nExclusion Criteria:\n\n* Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator\n* Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)\n* Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator\n* Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator\n* 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\\])\n* Positive urine drug screen for opiates, cocaine, or amphetamines at screening\n* Positive pregnancy test before imaging\n* Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent\n* Previous scan with any DAT imaging agent (e.g. \\[123I\\]NAV5001, Altropane, DaTscan, DOPASCAN)\n* Any exposure to radiopharmaceuticals within 30 days before the date of informed consent\n* Breast-feeding\n* Inability to lie supine for 1 hour\n* Any thyroid disease other than adequately treated hypothyroidism\n* Known sensitivity or allergy to iodine or iodine containing products\n* 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.","ALL","40 Years",{"count":58,"type":59},13,"ACTUAL","INTERVENTIONAL",[62],"PHASE3","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.",[65],"Parkinson's Syndrome",[67],"Parkinson's Disease","TERMINATED","The entire drug development program for this molecule was sold to another company.","2018-10-04",{"date":72,"type":59},"2018-10-05",{"date":74,"type":11},"2013-11",{"date":76,"type":59},"2018-01",{"name":5,"class":6},2]