Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-03 @ 7:12 PM
Study NCT ID:
NCT01950468
Status:
WITHDRAWN
Last Update Posted:
2017-09-13
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C519528', 'term': 'ioflupane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The entire drug development program for this molecule was sold to another company.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of positve DaTscan SPECT brain scans', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease"], 'conditions': ["Parkinson's Syndrome"]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\< 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.'}, 'identificationModule': {'nctId': 'NCT01950468', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Navidea Biopharmaceuticals'}, 'officialTitle': 'Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes', 'orgStudyIdInfo': {'id': 'NAV5-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAV5001', 'interventionNames': ['Drug: NAV5001']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DaTscan', 'interventionNames': ['Drug: DaTscan']}], 'interventions': [{'name': 'NAV5001', 'type': 'DRUG', 'description': 'A single intravenous dose of 8.0 ± 1.0 mCi', 'armGroupLabels': ['NAV5001']}, {'name': 'DaTscan', 'type': 'DRUG', 'description': 'A single intravenous dose of 3 to 5 mCi', 'armGroupLabels': ['DaTscan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Xenoscience, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Cornelia Reininger, M.D. Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Navidea Biopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navidea Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}