Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 4:42 AM
Study NCT ID:
NCT04580394
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Crossover Trial of AD109 in Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@apnimed.com', 'phone': '6175008880', 'title': 'Clinical Trials', 'organization': 'Apnimed, Inc.'}, 'certainAgreement': {'otherDetails': 'PIs agreed that because the Study is part of a Multi-center Study, individual publication could not be made until the publication of the Multi-center study results, notification that that a Multi-center publication was not planned, or after 18 months had passed', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were monitored for 14 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 8 weeks; End of Study Evaluation, 2 weeks post crossover period).', 'description': 'The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.', 'eventGroups': [{'id': 'EG000', 'title': 'A: AD109', 'description': 'Treatment A: AD109 (Atomoxetine 75 mg + R-oxybutynin 2.5 mg)', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 2, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'B: Atomoxetine 75 mg + Placebo', 'description': 'Treatment B: Atomoxetine 75 mg + Placebo', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 2, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'C: R-oxybutynin 2.5 mg + Placebo', 'description': 'Treatment C:R-oxybutynin 2.5 mg + Placebo', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'D:Placebo + Placebo', 'description': 'Treatment D: Placebo + Placebo', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac Arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'notes': 'Pre-treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AD109', 'description': 'Oral capsule administered before sleep\n\nAD109: Oral administration before bed'}, {'id': 'OG001', 'title': 'Atomoxetine', 'description': 'Oral capsule administered before sleep\n\nAtomoxetine: Oral administration before bed'}, {'id': 'OG002', 'title': 'R-oxybutynin', 'description': 'Oral capsule administered before sleep\n\nR-oxybutynin: Oral administration before bed'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Oral capsule administered before sleep\n\nPlacebo: Oral administration before bed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '-0.28'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-0.49', 'upperLimit': '-0.23'}, {'value': '-0.04', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.09'}, {'value': '-0.06', 'groupId': 'OG003', 'lowerLimit': '-0.18', 'upperLimit': '0.07'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 night (treatment duration) (0-8 hours collected continuously)', 'description': "Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\\[% min/hour\\]. Events with 4% or greater desaturations were included in the calculation of HB.", 'unitOfMeasure': 'Log10HB4%[%min/hour]', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy was analyzed using the mITT Set comprised of all participants who took at least 1 dose of any of the study treatments and had at least 1 measurement for the primary endpoint. Fifty-nine (98.3%) participants were included in the mITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Oral capsules were administered before sleep in random order of each of the following: AD109 (Treatment A: Atomoxetine 75 mg and R-Oxbutynin 2.5 mg), Treatment B: Atomoxetine 75 mg and Placebo, Treatment C:R-Oxbutynin 2.5 mg and placebo, Treatment D:Placebo and Placebo. Each participant received single doses of each of the four treatments, the order in which each treatment was assigned was random.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': '75mg/2.5mg', 'comment': 'Treatment A: Atomoxetine 75 mg and R-oxybutynin 2.5 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': '75mg and Placebo', 'comment': 'Treatment B: Atomoxetine 75 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': '2.5mg and Placebo', 'comment': 'Treatment C: R-oxybutynin 2.5 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Placebo and Placebo', 'comment': 'Treatment D', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Incorrectly Randomized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': '75mg/2.5mg', 'comment': 'Treatment A: Atomoxetine 75 mg and R-oxybutynin 2.5 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': '75mg and Placebo', 'comment': 'Treatment B: Atomoxetine 75 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': '2.5mg and Placebo', 'comment': 'Treatment C: R-oxybutynin 2.5 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Placebo and Placebo', 'comment': 'Treatment D', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': '75mg /2.5mg', 'comment': 'Treatment A: Atomoxetine 75 mg and R-oxybutynin 2.5 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': '75mg and Placebo', 'comment': 'Treatment B: Atomoxetine 75 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': '2.5mg and Placebo', 'comment': 'Treatment C: R-oxybutynin 2.5 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Placebo and Placebo', 'comment': 'Treatment D', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Fourth Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': '75mg/2.5mg', 'comment': 'Treatment A: Atomoxetine 75 mg and R-oxybutynin 2.5 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': '75mg and Placebo', 'comment': 'Treatment B: Atomoxetine 75 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': '2.5mg and Placebo', 'comment': 'Treatment C: R-oxybutynin 2.5 mg and placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Placebo and Placebo', 'comment': 'Treatment D', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Seven clinical sites screened 146 participants, 60 participants were randomized. This was a double-blind, single dose crossover study. Participants underwent initial pre-screening to determine potential study eligibility. Overall study duration was up to 14 weeks. Participants who withdrew from the study were not replaced.', 'preAssignmentDetails': 'Participants underwent initial pre-screening to determine potential study eligibility. Patients selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or had high risk.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Oral capsule administered before sleep\n\nAD109 Atomoxetine R-Oxybutynin Placebo'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-06', 'size': 1043373, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-19T14:30', 'hasProtocol': True}, {'date': '2021-05-13', 'size': 1107828, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-19T14:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2020-10-02', 'resultsFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-12', 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]', 'timeFrame': '1 night (treatment duration) (0-8 hours collected continuously)', 'description': "Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\\[% min/hour\\]. Events with 4% or greater desaturations were included in the calculation of HB."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.', 'detailedDescription': 'The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.\n* AHI 10 to \\<20, or AHI ≥20 if meets other PSG criteria\n\nExclusion Criteria:\n\n* History of narcolepsy.\n* Clinically significant craniofacial malformation.\n* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication\n* CPAP should not be used for at least 2 weeks prior to first study PSG\n* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.'}, 'identificationModule': {'nctId': 'NCT04580394', 'briefTitle': 'Crossover Trial of AD109 in Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apnimed'}, 'officialTitle': 'Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'APC-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AD109', 'description': 'Oral capsule administered before sleep', 'interventionNames': ['Drug: AD109', 'Diagnostic Test: Digit System Substitution Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atomoxetine', 'description': 'Oral capsule administered before sleep', 'interventionNames': ['Drug: Atomoxetine', 'Diagnostic Test: Digit System Substitution Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R-oxybutynin', 'description': 'Oral capsule administered before sleep', 'interventionNames': ['Drug: R-oxybutynin', 'Diagnostic Test: Digit System Substitution Test']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral capsule administered before sleep', 'interventionNames': ['Drug: Placebo', 'Diagnostic Test: Digit System Substitution Test']}], 'interventions': [{'name': 'AD109', 'type': 'DRUG', 'description': 'Oral administration before bed', 'armGroupLabels': ['AD109']}, {'name': 'Atomoxetine', 'type': 'DRUG', 'description': 'Oral administration before bed', 'armGroupLabels': ['Atomoxetine']}, {'name': 'R-oxybutynin', 'type': 'DRUG', 'description': 'Oral administration before bed', 'armGroupLabels': ['R-oxybutynin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration before bed', 'armGroupLabels': ['Placebo']}, {'name': 'Digit System Substitution Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['DSST'], 'description': 'a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.', 'armGroupLabels': ['AD109', 'Atomoxetine', 'Placebo', 'R-oxybutynin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Empire Clinical Research', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Teradan Clinical Trials', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Trials of Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Neurological Center of North Georgia', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apnimed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}