Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-03-07 @ 9:13 PM
Study NCT ID:
NCT02410902
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2015-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.gannon@curemark.com', 'phone': '914-824-9716', 'title': 'William E. Gannon, Jr MD, Medical Director', 'organization': 'Curemark'}, 'certainAgreement': {'otherDetails': "Publications include input from PI and Curemark reflected in authorship. Institution's results may be submitted after results of the multicenter study are published, 18m after completion, or if multicenter publication isn't planned. Then PI may to publish, subject to confidentiality agreement. PI shall give to Curemark 45 days prior for review. Submission of such publication of results be can't delayed more than 105d after being received by Curemark. After 105 days, the PI may publish.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were recorded from the time of consent through 30-days following subject completion of or withdrawal from study, equalling a maximum of 128 days.', 'eventGroups': [{'id': 'EG000', 'title': 'CM-AT', 'description': 'Active substance in single unit dose powder\n\nCM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 79, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo powder of inactive substance\n\nPLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 90, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 35, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Stool pH Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 28, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Stool Analysis Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Clostridium Test Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Stool pH Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Outcome Measurements to Determine Efficacy of Treatment With CM-AT Versus Placebo for Changes in the Aberrant Behavior Checklist Subscale for Irritability / Agitation (ABC-I) Between Baseline and Week 12/Termination Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CM-AT', 'description': 'Active substance in single unit dose powder\n\nParticipants were between 3 through to 6 years old inclusive and took 900mg CM-AT. Participants took 3 sachets of CM-AT in total: One at each meal'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo powder of inactive substance\n\nParticipants were between 3 through to 6 years old inclusive and took 900mg Placebo. Participants took 3 sachets of Placebo in total: One at each meal'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.0', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '9.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-4.98', 'ciUpperLimit': '-0.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'ANCOVA using MMRM analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Screening through Week 12/Termination', 'description': "Primary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist (ABC) - Community sub scale for Irritability/Agitation (ABC-I) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-I is one of five discrete sub scales measured by the ABC. The scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. The score was automatically calculated by the EDC.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome Measurements of Changes in the Aberrant Behavior Checklist Checklist Subscale for Lethargy / Social Withdrawal (ABC-L) Between Baseline and Week 12/Termination Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CM-AT', 'description': 'Active substance in single unit dose powder\n\nParticipants were between 3 through to 6 years old inclusive and took 900mg CM-AT. Participants took 3 sachets of CM-AT in total: One at each meal.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo powder of inactive substance\n\nParticipants were between 3 through to 6 years old inclusive and took 900mg Placebo. Participants took 3 sachets of Placebo in total: One at each meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '9.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-3.21', 'ciUpperLimit': '1.07', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'ANCOVA using MMRM analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Screening through Week 12/Termination.', 'description': "Secondary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist- Community (ABC) sub scale for Lethargy / Social Withdrawal (ABC-L) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-L is one of five discrete sub scales measured by the ABC. The scale range is 0-48. A higher score reflects higher severity of symptoms (lethargy). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CM-AT', 'description': 'Active substance in single unit dose powder\n\nCM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo powder of inactive substance\n\nPLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'ITT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited across 33 sites in the USA. The First Subject First Visit (FSFV) occurred on 03 June 2015 (First screening visit date) and the Last Subject Last Visit (LSLV) occurred on 20 December 2017.', 'preAssignmentDetails': 'Participants were screened for autistic disorder using the Diagnostic Statistical Manual of Mental Disorders Fourth Edition - Text Revised (DSM-IV-TR); and the Social Communication Questionnaire (SCQ), with diagnostic confirmation by the Autism Diagnostic Interview-Revised (ADI-R). All qualifying participants were given a 2 week run-in period and then reassessed for eligibility and then randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CM-AT', 'description': 'Active substance in single unit dose powder\n\nCM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo powder of inactive substance\n\nPLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ABC-I', 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '23.4', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '22.8', 'spread': '7.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ABC-I is a discrete sub scale of the Aberrant Behavior Checklist (ABC) - Community. The "I" is the Irritability sub scale. Scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). The Baseline measurement indicates the subject\'s initial score on this sub scale. Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on scale (0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree). Questions correspond to one of 5 sub scales.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-17', 'size': 215912, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-03T16:24', 'hasProtocol': True}, {'date': '2017-12-27', 'size': 482992, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-03T16:26', 'hasProtocol': False}]}}, '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': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2018-12-19', 'completionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2015-03-19', 'dispFirstSubmitQcDate': '2018-12-19', 'resultsFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2015-04-02', 'dispFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-28', 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measurements to Determine Efficacy of Treatment With CM-AT Versus Placebo for Changes in the Aberrant Behavior Checklist Subscale for Irritability / Agitation (ABC-I) Between Baseline and Week 12/Termination Visit', 'timeFrame': 'Screening through Week 12/Termination', 'description': "Primary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist (ABC) - Community sub scale for Irritability/Agitation (ABC-I) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-I is one of five discrete sub scales measured by the ABC. The scale range is 0-45. A higher score reflects higher severity of symptoms (irritability). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree. The score was automatically calculated by the EDC."}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome Measurements of Changes in the Aberrant Behavior Checklist Checklist Subscale for Lethargy / Social Withdrawal (ABC-L) Between Baseline and Week 12/Termination Visit', 'timeFrame': 'Screening through Week 12/Termination.', 'description': "Secondary outcome measurements to determine efficacy of treatment with CM-AT versus Placebo for changes in the Aberrant Behavior Checklist- Community (ABC) sub scale for Lethargy / Social Withdrawal (ABC-L) between baseline (subject's initial measurement) and Week 12/Termination (subject's final measurement) visit. Participants were between 3 through to 6 years old inclusive and took 900mg CM-AT or Placebo three times daily. The ABC-L is one of five discrete sub scales measured by the ABC. The scale range is 0-48. A higher score reflects higher severity of symptoms (lethargy). Scores are obtained via Parent Rated Questionnaire. Parents respond to a series of questions on a scale directly into an electronic data capture system (EDC), responding: 0 = not at all a problem 1 = the behavior is a problem but slight in degree 2 = the problem is moderately serious 3 = the problem is severe in degree."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Autism'], 'conditions': ['Autism']}, 'referencesModule': {'references': [{'pmid': '21464191', 'type': 'BACKGROUND', 'citation': 'McPheeters ML, Warren Z, Sathe N, Bruzek JL, Krishnaswami S, Jerome RN, Veenstra-Vanderweele J. A systematic review of medical treatments for children with autism spectrum disorders. Pediatrics. 2011 May;127(5):e1312-21. doi: 10.1542/peds.2011-0427. Epub 2011 Apr 4.'}, {'pmid': '22456193', 'type': 'BACKGROUND', 'citation': 'Autism and Developmental Disabilities Monitoring Network Surveillance Year 2008 Principal Investigators; Centers for Disease Control and Prevention. Prevalence of autism spectrum disorders--Autism and Developmental Disabilities Monitoring Network, 14 sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30;61(3):1-19.'}, {'pmid': '24670961', 'type': 'BACKGROUND', 'citation': 'Developmental Disabilities Monitoring Network Surveillance Year 2010 Principal Investigators; Centers for Disease Control and Prevention (CDC). Prevalence of autism spectrum disorder among children aged 8 years - autism and developmental disabilities monitoring network, 11 sites, United States, 2010. MMWR Surveill Summ. 2014 Mar 28;63(2):1-21.'}, {'pmid': '22157409', 'type': 'BACKGROUND', 'citation': 'Peacock G, Amendah D, Ouyang L, Grosse SD. Autism spectrum disorders and health care expenditures: the effects of co-occurring conditions. J Dev Behav Pediatr. 2012 Jan;33(1):2-8. doi: 10.1097/DBP.0b013e31823969de.'}, {'pmid': '17404130', 'type': 'BACKGROUND', 'citation': 'Ganz ML. The lifetime distribution of the incremental societal costs of autism. 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Co-occurring conditions associated with FMR1 gene variations: findings from a national parent survey. Am J Med Genet A. 2008 Aug 15;146A(16):2060-9. doi: 10.1002/ajmg.a.32439.'}, {'pmid': '16283084', 'type': 'BACKGROUND', 'citation': 'Lecavalier L. An evaluation of the Gilliam Autism Rating Scale. J Autism Dev Disord. 2005 Dec;35(6):795-805. doi: 10.1007/s10803-005-0025-6.'}, {'pmid': '19797985', 'type': 'BACKGROUND', 'citation': 'Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658.'}, {'pmid': '19998356', 'type': 'BACKGROUND', 'citation': 'Yerys BE, Wallace GL, Sokoloff JL, Shook DA, James JD, Kenworthy L. Attention deficit/hyperactivity disorder symptoms moderate cognition and behavior in children with autism spectrum disorders. Autism Res. 2009 Dec;2(6):322-33. doi: 10.1002/aur.103.'}, {'pmid': '16043324', 'type': 'BACKGROUND', 'citation': 'Schreck KA, Williams K. Food preferences and factors influencing food selectivity for children with autism spectrum disorders. Res Dev Disabil. 2006 Jul-Aug;27(4):353-63. doi: 10.1016/j.ridd.2005.03.005. Epub 2005 Jul 25.'}, {'pmid': '16217179', 'type': 'BACKGROUND', 'citation': 'Borowitz D. Update on the evaluation of pancreatic exocrine status in cystic fibrosis. Curr Opin Pulm Med. 2005 Nov;11(6):524-7. doi: 10.1097/01.mcp.0000181474.08058.b3.'}, {'pmid': '17304111', 'type': 'BACKGROUND', 'citation': 'Penn AH, Hugli TE, Schmid-Schonbein GW. Pancreatic enzymes generate cytotoxic mediators in the intestine. Shock. 2007 Mar;27(3):296-304. doi: 10.1097/01.shk.0000235139.20775.7f.'}, {'pmid': '20687077', 'type': 'BACKGROUND', 'citation': 'Williams K, Wheeler DM, Silove N, Hazell P. Selective serotonin reuptake inhibitors (SSRIs) for autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2010 Aug 4;(8):CD004677. doi: 10.1002/14651858.CD004677.pub2.'}, {'pmid': '38032645', 'type': 'DERIVED', 'citation': 'Pearson DA, Hendren RL, Heil MF, McIntyre WR, Raines SR. Pancreatic Replacement Therapy for Maladaptive Behaviors in Preschool Children With Autism Spectrum Disorder. JAMA Netw Open. 2023 Nov 1;6(11):e2344136. doi: 10.1001/jamanetworkopen.2023.44136.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.', 'detailedDescription': 'Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR) for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R;\n\nExclusion Criteria:\n\n* Patient weighing \\< 13kg (28.6 lbs)\n* Previous allergy to porcine (pork) products\n* Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease\n* Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease\n* Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid condition which in the Investigator's or Medical Director's opinion makes it undesirable for the subject to participate in the study or jeopardizes compliance with the protocol;\n* Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion);\n* Ongoing dietary restriction for allergy or other reasons except nut allergies (lactose-free allowable);\n* Use of of any stimulant medication must be discontinued 5 days prior to entering the study.\n* Subject must have a stable dose of SSRI's for at least 30 days.\n* Inability to ingest study drug and/or follow prescribed dosing schedule"}, 'identificationModule': {'nctId': 'NCT02410902', 'briefTitle': 'A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Curemark'}, 'officialTitle': 'A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)', 'orgStudyIdInfo': {'id': '00103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CM-AT', 'description': 'Active substance in single unit dose powder', 'interventionNames': ['Drug: CM-AT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo powder of inactive substance', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'CM-AT', 'type': 'DRUG', 'description': 'Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days', 'armGroupLabels': ['CM-AT']}, {'name': 'PLACEBO', 'type': 'DRUG', 'otherNames': ['placebo powder'], 'description': 'Single unit dose powder of non-active substance administered 3 times per day for 90 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Autism Research & Resource Center (S.A.R.R.C.)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona, Pediatrics Multidisciplinary Research Unit', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children'S Hosp. 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