Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-30 @ 2:48 PM
Study NCT ID:
NCT04644003
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@stalicla.com', 'phone': '+41 (0)79 918 33 16', 'title': 'Eric Painbeni, PhD - Head of Clinical Operations', 'organization': 'STALICLA SA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The total duration of the study for each participant was up to six weeks divided as follows: a screening phase of two weeks (from Day -14 to Day -1); a double-blind treatment phase of two weeks (from Day 1 to Day 14); and a follow-up phase of two weeks after treatment discontinuation (from Day 15 to Day 28).', 'description': 'As per ClinicalTrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'STP1 Low Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'STP1 High Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': '1 placebo capsule and 1 placebo tablet per intake\n\nPlacebo: Placebo medication (capsule and tablet) identical in appearance to active medication', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Trichotillomania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'STP1 Low Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor'}, {'id': 'OG001', 'title': 'STP1 High Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 placebo capsule and 1 placebo tablet per intake\n\nPlacebo: Placebo medication (capsule and tablet) identical in appearance to active medication'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Number of Participants with Adverse Events (nature and frequency of non-serious adverse events, serious adverse events and adverse events of special interest).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients receiving at least 1 dose of randomised treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STP1 Low Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor'}, {'id': 'FG001', 'title': 'STP1 High Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor'}, {'id': 'FG002', 'title': 'Placebo', 'description': '1 placebo capsule and 1 placebo tablet per intake\n\nPlacebo: Placebo medication (capsule and tablet) identical in appearance to active medication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patient population is defined as ASD-Phen1 based on STALICLA criteria. The number of patients enrolled were 12 subjects with 6 subjects receiving STP1-Low Dose, 3 subjects receiving STP1-High Dose, and 3 subjects receiving placebo. All 12 subjects (100.0%) completed treatment with 0 screen failures.', 'preAssignmentDetails': 'Of 12 enrolled participants, 12 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'STP1 Low Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor'}, {'id': 'BG001', 'title': 'STP1 High Dose', 'description': '1 capsule and 1 tablet per intake\n\nSTP1: STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor'}, {'id': 'BG002', 'title': 'Placebo', 'description': '1 placebo capsule and 1 placebo tablet per intake\n\nPlacebo: Placebo medication (capsule and tablet) identical in appearance to active medication'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.67', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '19.67', 'spread': '1.53', 'groupId': 'BG001'}, {'value': '19.67', 'spread': '2.89', 'groupId': 'BG002'}, {'value': '19.17', 'spread': '1.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.50', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '20.0'}, {'value': '20.00', 'groupId': 'BG001', 'lowerLimit': '18.0', 'upperLimit': '21.0'}, {'value': '18.00', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '23.0'}, {'value': '18.50', 'groupId': 'BG003', 'lowerLimit': '18.0', 'upperLimit': '23.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '36.80', 'spread': '5.02', 'groupId': 'BG000'}, {'value': '37.07', 'spread': '6.89', 'groupId': 'BG001'}, {'value': '25.17', 'spread': '5.84', 'groupId': 'BG002'}, {'value': '33.96', 'spread': '7.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "BMI is calculated by dividing the participant's weight in kilograms by the height in metres squared.", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-15', 'size': 13700693, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-12T10:34', 'hasProtocol': True}, {'date': '2022-02-17', 'size': 2475074, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-12T10:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2020-11-16', 'resultsFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-28', 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '14 days', 'description': 'Number of Participants with Adverse Events (nature and frequency of non-serious adverse events, serious adverse events and adverse events of special interest).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASD', 'Autism Spectrum Disorder'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '39062003', 'type': 'DERIVED', 'citation': 'Erickson CA, Perez-Cano L, Pedapati EV, Painbeni E, Bonfils G, Schmitt LM, Sachs H, Nelson M, De Stefano L, Westerkamp G, de Souza ALS, Pohl O, Laufer O, Issachar G, Blaettler T, Hyvelin JM, Durham LA. Safety, Tolerability, and EEG-Based Target Engagement of STP1 (PDE3,4 Inhibitor and NKCC1 Antagonist) in a Randomized Clinical Trial in a Subgroup of Patients with ASD. Biomedicines. 2024 Jun 27;12(7):1430. doi: 10.3390/biomedicines12071430.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD). In addition, Pharmacokinetics and Pharmacodynamics, as well as efficacy of STP1 are being explored.', 'detailedDescription': 'After obtaining written informed consent, those patients who are deemed eligible for the study, will be randomized on Day 1, in a double-blinded manner, in a 3:1ratio to receive either oral STP1 (twice daily) or placebo (twice daily). The total study duration is 6 weeks, including a screening phase of up to 2 weeks, a treatment phase of 2 weeks and a post-treatment follow-up phase of 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Male or female individuals, between 18 and 40 years, diagnosed of ASD.\n2. Patients will be assessed for specific developmental anthropometric \\& anatomical criteria as well as personal and family medical history as assessed by the ASD-Phen1 semi structured interview form.\n3. Patients must have a parent or reliable caregiver who can provide information about the pre-natal period and early developmental period, as required by the protocol.\n4. Patient and/or parent or legal guardian willing and consenting to participate.\n5. Patients with ASD and comorbid seizure disorder should be seizure-free for at least 6 months prior to screening.\n6. Before enrolling in the study, subjects must agree to use double-barrier birth control methods if they engage in intercourse.\n\nKey Exclusion Criteria:\n\n1. Patients with an identified genetic cause of ASD in their medical record will be excluded from the study.\n2. History of traumatic head injury, cerebrovascular disorder, congestive heart failure, hepatic or renal disease.\n3. Thrombocytopenia.\n4. Type 1 Diabetes Mellitus or uncontrolled type 2 Diabetes Mellitus, or latent autoimmune diabetes of the adult.\n5. A significant risk for suicidal behavior.\n6. Initiation of, or a major change in psychological / behavioral intervention within 4 weeks prior to randomization.\n7. Patient with any active infection.\n8. Systolic blood pressure (SBP) \\<80 mmHg or diastolic blood pressure (DBP) \\<40 mmHg or a drop in SBP of ≥20 mm Hg, or in DBP of ≥10 mm Hg, during the orthostatic recordings.\n9. Clinically relevant electrocardiogram (ECG) abnormalities.\n10. Clinically significant abnormal laboratory test.\n11. Active clinically significant disease.\n12. History of malignancy.\n13. Pregnant (confirmed by laboratory testing) or lactating female patient.'}, 'identificationModule': {'nctId': 'NCT04644003', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stalicla SA'}, 'officialTitle': 'A Phase 1b, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate Safety, Tolerability and Pharmacokinetics of a Two-Week Oral Treatment With STP1 in a Subgroup of Patients With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'STP1-C004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STP1 Low Dose', 'description': '1 capsule and 1 tablet per intake', 'interventionNames': ['Drug: STP1']}, {'type': 'EXPERIMENTAL', 'label': 'STP1 High Dose', 'description': '1 capsule and 1 tablet per intake', 'interventionNames': ['Drug: STP1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 placebo capsule and 1 placebo tablet per intake', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'STP1', 'type': 'DRUG', 'description': 'STP1 is a combination of two drugs, a phosphodiesterase (PDE) inhibitor and an NKCC1 inhibitor', 'armGroupLabels': ['STP1 High Dose', 'STP1 Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo medication (capsule and tablet) identical in appearance to active medication', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Craig Erickson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stalicla SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}