Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT05523895
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2022-08-29
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'interventionBrowseModule': {'meshes': [{'id': 'C510793', 'term': 'pimavanserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinformation@acadia-pharm.com', 'phone': '858-261-2289', 'title': 'Sr. Dir. Medical Information and Medical Communications', 'organization': 'Acadia Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': "Investigator may publish the study results, relative to their own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the Sponsor for review and comment. The sponsor has 60 days to review and comment.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening to end of safety follow-up, which was to be performed at 10 weeks, i.e. 4 weeks after last dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Pimavanserin-matching placebo, given as 1 capsule once daily', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 11, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pimavanserin Low Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 10 mg/day; patients aged 13-17 years: 20 mg/day', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 17, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pimavanserin High Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 20 mg/day; patients aged 13-17 years: 34mg/day', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 16, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pimavanserin-matching placebo, given as 1 capsule once daily'}, {'id': 'OG001', 'title': 'Pimavanserin Low Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 10 mg/day; patients aged 13-17 years: 20 mg/day'}, {'id': 'OG002', 'title': 'Pimavanserin High Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 20 mg/day; patients aged 13-17 years: 34mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.6', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-11.2', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '-11.2', 'spread': '1.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2986', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.49', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'The Aberrant Behavior Checklist (ABC) is a caregiver-rated scale comprised of 5 empirically-derived subscales encompassing 58 items that describe various behavior problems. It measures domains of irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. ABC-I is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A score for each item ranges from 0 indicating "not at all a problem" to 3 indicating "the problem is severe in degree". Subscale scores are calculated by summing the items within that subscale. Higher scores indicate greater impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized patients who received at least one dose of study drug and have a baseline value and at least one post-baseline value for the ABC-I subscale score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Pimavanserin-matching placebo, given as 1 capsule once daily'}, {'id': 'FG001', 'title': 'Pimavanserin Low Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 10 mg/day; patients aged 13-17 years: 20 mg/day'}, {'id': 'FG002', 'title': 'Pimavanserin High Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 20 mg/day; patients aged 13-17 years: 34mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Not further specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '237', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Pimavanserin-matching placebo, given as 1 capsule once daily'}, {'id': 'BG001', 'title': 'Pimavanserin Low Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 10 mg/day; patients aged 13-17 years: 20 mg/day'}, {'id': 'BG002', 'title': 'Pimavanserin High Dose', 'description': 'Pimavanserin given as 1 capsule once daily. Patients aged 5-12 years: 20 mg/day; patients aged 13-17 years: 34mg/day'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '2.88', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '3.54', 'groupId': 'BG001'}, {'value': '9.8', 'spread': '3.11', 'groupId': 'BG002'}, {'value': '9.8', 'spread': '3.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '5-12 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}]}, {'title': '13-17 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All patients randomised'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-21', 'size': 1438323, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-25T09:02', 'hasProtocol': True}, {'date': '2024-10-12', 'size': 1451836, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-25T09:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2022-08-29', 'resultsFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-07', 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score', 'timeFrame': '6 weeks', 'description': 'The Aberrant Behavior Checklist (ABC) is a caregiver-rated scale comprised of 5 empirically-derived subscales encompassing 58 items that describe various behavior problems. It measures domains of irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. ABC-I is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A score for each item ranges from 0 indicating "not at all a problem" to 3 indicating "the problem is severe in degree". Subscale scores are calculated by summing the items within that subscale. Higher scores indicate greater impairment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized', 'Placebo-controlled'], 'conditions': ['Irritability Associated With Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin', 'detailedDescription': 'This study will be conducted as a 6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (5 through 17 years of age) with ASD with irritability, agitation, or self-injurious behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Male or female and 5 through 17 years of age\n* Informed consent prior to the conduct of any study procedures\n* Patients (to the best of his/her ability), parent/legally accepted representative, and designated caregiver (if applicable) are able to understand the nature of the study, follow protocol requirements, and be willing to comply with study drug administration requirements\n* Able to swallow a test placebo capsule without difficulty\n* Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ASD (APA 2013) and diagnosis is confirmed by the Autism Diagnostic Interview-Revised (ADI-R)\n* Score ≥18 on the Irritability subscale of the Aberrant Behavior Checklist (ABC)\n* Score ≥4 (moderate or greater severity) on the Clinical Global Impression-Severity (CGI-S) of irritability score\n* No current comorbid psychiatric disorder other than attention-deficit hyperactivity disorder (ADHD) or anxiety disorder\n* Drug-naïve to antipsychotic treatment (or \\<2 weeks antipsychotic treatment for any reason), or prior lack of tolerability to adequate dose of any duration of antipsychotic confirmed by caregiver and medical records review\n* If patient is undergoing concurrent behavioral therapy for autism related symptoms or behaviors, this non-pharmacological treatment regimen has been stable for at least 4 weeks, and will be consistent throughout the study\n* For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test\n\nEXCLUSION CRITERIA:\n\n* Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the QT interval, and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers\n* Changes in medications or medication doses (for medical and allowed comorbid psychiatric conditions) in the last 4 weeks\n* Any known history of angioedema, serotonin or neuroleptic malignant syndromes, dystonic reaction, or tardive dyskinesia, due to an antipsychotic or psychotropic medication\n* At a significant risk of suicide, or is a danger to self or others\n* At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others\n* Positive urine drug test\n* Met DSM-5 criteria for substance use disorders within the last 6 months\n* Confirmed genetic disorder associated with ASD, a cognitive and/ or behavioral disturbance or profound intellectual disability (IQ ≤50)\n* History of seizures, unless seizure-free and off epileptic drugs for at least 6 months\n* Any condition that, in the opinion of the Investigator, would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk\n* Current evidence, or history within the last 12 weeks, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies\n* Weight \\<15 kg\n* History or presence on at least one ECG of protocol-defined cardiac conduction abnormalities\n* Known family or personal history or symptoms of long QT syndrome or history of cardiac arrhythmias or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval\n* Any member of the household has suffered from COVID-19 or had a COVID-19 (PCR or immunoglobulin) positive test in the last 4 weeks\n* One or more clinical laboratory test value outside of protocol-defined limits\n* Breastfeeding or lactating, or has a positive pregnancy test result (for patients of childbearing potential)\n* Sensitivity to pimavanserin or any of the excipients\n* Participating in another clinical study of any investigational drug, device, or intervention\n* Participated in greater than 2 interventional pharmaceutical clinical research studies in the last 6 months\n* Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.'}, 'identificationModule': {'nctId': 'NCT05523895', 'briefTitle': 'Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'ACADIA Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'ACP-103-069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo given once daily, as one capsule matching in size and color the respective pimavanserin treatment', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Pimavanserin low dose', 'description': "Patients aged 5 to 12 years: 10 mg/day pimavanserin Patients aged 13 to 17 years: 20 mg/day pimavanserin\n\nPimavanserin given once daily, as capsule of 10 or 20 mg dose strength, respectively, according to the patient's age", 'interventionNames': ['Drug: Pimavanserin']}, {'type': 'EXPERIMENTAL', 'label': 'Pimavanserin high dose', 'description': "Patients aged 5 to 12 years: 20 mg/day pimavanserin Patients aged 13 to 17 years: 34 mg/day pimavanserin\n\nPimavanserin given once daily, as capsule of 20 or 34 mg dose strength, respectively, according to the patient's age", 'interventionNames': ['Drug: Pimavanserin']}], 'interventions': [{'name': 'Pimavanserin', 'type': 'DRUG', 'otherNames': ['Nuplazid'], 'description': 'Pimavanserin', 'armGroupLabels': ['Pimavanserin high dose', 'Pimavanserin low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pimavanserin matching placebo', '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': '91361', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Cortica Inc. 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