Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 5:27 PM
Study NCT ID:
NCT01282268
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2011-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005600', 'term': 'Fragile X Syndrome'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'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'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543531', 'term': 'arbaclofen placarbil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2011-01-21', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aberrant Behavior Checklist - FXS Social Avoidance Subscale', 'timeFrame': 'At 8 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fragile X syndrome', 'autism spectrum disorder'], 'conditions': ['Fragile X Syndrome']}, 'descriptionModule': {'briefSummary': 'To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Molecular documentation of the full FMR1 mutation\n* Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.\n* Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.\n* If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening\n\nExclusion Criteria:\n\n* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.\n* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.\n* Subjects who have taken another investigational drug within the last 30 days.\n* Subjects who are not able to take oral medications.'}, 'identificationModule': {'nctId': 'NCT01282268', 'acronym': 'Harbor-A', 'briefTitle': 'Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seaside Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome', 'orgStudyIdInfo': {'id': '209FX301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arbaclofen', 'interventionNames': ['Drug: arbaclofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'arbaclofen', 'type': 'DRUG', 'otherNames': ['STX209'], 'description': 'orally disintegrating tablet', 'armGroupLabels': ['Arbaclofen']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'orally disintegrating tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Autism Research & Resource Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital Research Administration", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis, M.I.N.D. Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Psychiatric Centers at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "University of Colorado Denver, Children's Hospital", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Mailman Center for Child Development', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Lake Mary Pediatrics', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Seaver Autism Center, Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Institute for Basic Research in Developmental Disabilities', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '27005', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Clinical Research Unit', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "University of Oklahoma, Physician's Child Study Center", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Suburban Research Associates/Elwyn Genetics', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Kennedy Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Red Oaks Psychiatry Associates, P.A.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Road Runner Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Paul Wang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seaside Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seaside Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}