Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-04-25 @ 7:01 PM
Study NCT ID:
NCT03233867
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2017-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2503}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects between the ages of 6 and 17 years, who have been told that they have ADHD, will be eligible for screening.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Parent/legally authorized representative (LAR) can speak and read English fluently, have provided informed consent and agree to be contacted for an interventional study prior to being genotyped.\n2. Subject is 6 to 17 years of age (inclusive) at the time of informed consent.\n3. Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD.\n4. Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.\n\nExclusion Criteria:\n\n1. Parent/LAR confirms that the subject has been diagnosed with any of the following conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression, autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure disorder, syncope, or other serious cardiac problems.\n2. Aside from your child's current ADHD medication (if applicable), parent/LAR confirms that the subject is currently taking any of the following medications: antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers.\n3. Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study."}, 'identificationModule': {'nctId': 'NCT03233867', 'briefTitle': 'A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avalo Therapeutics, Inc.'}, 'officialTitle': 'A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity', 'orgStudyIdInfo': {'id': 'AEVI-001-ADHD-002'}}, 'contactsLocationsModule': {'locations': [{'zip': '19087', 'city': 'Wayne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Aevi Genomic Medicine', 'geoPoint': {'lat': 40.044, 'lon': -75.38769}}], 'overallOfficials': [{'name': 'Andrew Cutler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meridien Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aevi Genomic Medicine, LLC, a Cerecor company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}