Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-07 @ 9:53 PM
Study NCT ID:
NCT00686933
Status:
COMPLETED
Last Update Posted:
2013-01-21
First Post:
2008-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108326', 'term': 'pozanicline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2011-08-19', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-11', 'studyFirstSubmitDate': '2008-05-28', 'dispFirstSubmitQcDate': '2011-08-19', 'studyFirstSubmitQcDate': '2008-05-28', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CAARS:Inv', 'timeFrame': 'Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24'}, {'measure': 'CGI-ADHD-S', 'timeFrame': 'Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24'}], 'secondaryOutcomes': [{'measure': 'CAARS:Self', 'timeFrame': 'Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24'}, {'measure': 'BRIEF-A', 'timeFrame': 'Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24'}, {'measure': 'AAQOL', 'timeFrame': 'Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24'}, {'measure': 'WPAI', 'timeFrame': 'Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24'}, {'measure': 'FTND', 'timeFrame': 'Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attention-Deficit/Hyperactivity Disorder'], 'conditions': ['Attention-Deficit/Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject was randomized into Study M10-346 and completed the study.\n* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.\n* Male subjects must agree to comply with applicable contraceptive requirements.\n* The subject is judged to be in generally good health.\n\nExclusion Criteria:\n\n* The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study.\n* The subject anticipates a move outside the geographic area.'}, 'identificationModule': {'nctId': 'NCT00686933', 'briefTitle': 'Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study for Subjects Completing Study M10-346', 'orgStudyIdInfo': {'id': 'M10-425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ABT-089']}], 'interventions': [{'name': 'ABT-089', 'type': 'DRUG', 'description': 'Subjects will take up to 80 mg daily for 24 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8315', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8306', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8308', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8314', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '48336', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8307', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8318', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8309', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8316', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8310', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '23452', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8319', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8305', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8320', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Earle Bain, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}