[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205398":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":11,"locations":31,"responsibleParty":55,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":77,"whyStopped":78,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Navidea Biopharmaceuticals","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NAV5001","EXPERIMENTAL",null,[13],"Drug: NAV5001",{"label":15,"type":16,"description":11,"interventionNames":17},"DaTscan","ACTIVE_COMPARATOR",[18],"Drug: DaTscan",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","A single intravenous dose of 8.0 ± 1.0 mCi",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"A single intravenous dose of 3 to 5 mCi",[15],[28],{"name":29,"affiliation":5,"role":30},"Cornelia Reininger, M.D. Ph.D.","STUDY_DIRECTOR",[32,45],{"facility":33,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"Xenoscience, Inc.","Phoenix","Arizona","85004","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-112.07404,33.44838,{"lat":43,"lon":42},{"facility":46,"status":11,"city":47,"state":48,"zip":49,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":54,"contacts":11},"Compass Research","Orlando","Florida","32806",{"type":40,"coordinates":51},[52,53],-81.37924,28.53834,{"lat":53,"lon":52},{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100205398","phase-3-a-cross-over-multi-center-trial-to-evaluate-the-diagnostic-efficacy-and-safety-of-123inav5001-as-an-imaging-agent-to-aid-in-the-diagnosis-of-parkinsonian-syndromes-100205398",false,"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","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":67,"type":68},0,"ACTUAL","INTERVENTIONAL",[71],"PHASE3","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.",[74],"Parkinson's Syndrome",[76],"Parkinson's Disease","WITHDRAWN","The entire drug development program for this molecule was sold to another company.","2017-09-12",{"date":81,"type":68},"2017-09-13",{"date":83,"type":84},"2017-04","ESTIMATED",{"date":86,"type":84},"2018-03",{"name":5,"class":6},2]