Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-06-20 @ 8:42 PM
Study NCT ID:
NCT02719951
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2016-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glutaminergic Transmission in Autism : Molecular Imaging Exploration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D005600', 'term': 'Fragile X Syndrome'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral glutaminergic activity assessed by binding potential of [18F]FPEB', 'timeFrame': 'An average of 3 years'}], 'secondaryOutcomes': [{'measure': 'distribution volume of [18F]FPEB', 'timeFrame': 'An average of 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autism', 'fragile X syndrome (FXS)', 'PET (Positron Emission Tomography)', 'glutamate'], 'conditions': ['Autism', 'Fragile-X Syndrome (FXS)', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Between 18 years-old and 45 years-old\n* Informed, written consent obtained from patient or his representant\n* Subject with an affiliation to French social security\n* For autistic patient : patient with diagnosis of ASD (Autistic Spectrum Disorders) following DSM-IV or DSM-5 criteria with recommended tools (ADI-R and/or ADOS)\n* For FXS patient : diagnosis of FXS and confirmation of total mutation of FMR1\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* Excessive use of alcohol or drug, or addiction to alcohol or drug during last 6 months\n* Any unstable or uncontrolled disease, clinically significant\n* Participation to an other experimental protocol with drug or irradiant exam\n* Person under exclusion period because of previous participation to an other experimental protocol\n* Person under temporary guardianship\n* Forbidden treatments : any psychotropic treatment for 4 last weeks before PET exam and changing durably glutaminergic transmission directly or undirectly\n* For healthy subjects : adult under guardianship, medical history of central nervous system disease, medical history of attention deficit hyperactivity disorder, past or present psychiatric or neurologic disorder (MINI DSM-IV)'}, 'identificationModule': {'nctId': 'NCT02719951', 'acronym': 'TANGAU', 'briefTitle': 'Glutaminergic Transmission in Autism : Molecular Imaging Exploration', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Glutaminergic Transmission in Autism : Molecular Imaging Exploration', 'orgStudyIdInfo': {'id': 'PRIA 14 FBB / TANGAU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autistic patients', 'description': '\\[18F\\]FPEB PET imaging MRI (Magnetic Resonance Imaging) Biological samples', 'interventionNames': ['Drug: [18F]FPEB PET imaging', 'Other: Biological samples', 'Other: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'FXS patients', 'description': '\\[18F\\]FPEB PET imaging MRI Biological samples', 'interventionNames': ['Drug: [18F]FPEB PET imaging', 'Other: Biological samples', 'Other: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': '\\[18F\\]FPEB PET imaging MRI Biological samples', 'interventionNames': ['Drug: [18F]FPEB PET imaging', 'Other: Biological samples', 'Other: MRI']}], 'interventions': [{'name': '[18F]FPEB PET imaging', 'type': 'DRUG', 'description': 'PET exam', 'armGroupLabels': ['FXS patients', 'Healthy subjects', 'autistic patients']}, {'name': 'Biological samples', 'type': 'OTHER', 'description': 'blood sample and urine sample', 'armGroupLabels': ['FXS patients', 'Healthy subjects', 'autistic patients']}, {'name': 'MRI', 'type': 'OTHER', 'description': 'MRI exam', 'armGroupLabels': ['FXS patients', 'Healthy subjects', 'autistic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}