Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-01 @ 5:17 AM
Study NCT ID:
NCT05181995
Status:
TERMINATED
Last Update Posted:
2023-04-07
First Post:
2021-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
Sponsor:
Organization:
Raw JSON
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'2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)", 'timeFrame': 'study endpoint, up to 10 weeks', 'description': 'Change from Baseline in CAPS-5'}], 'secondaryOutcomes': [{'measure': 'CGI-S (Clinician Global Impression - Severity)', 'timeFrame': 'study endpoint, up to 10 weeks', 'description': 'Change from Baseline in CGI-S'}, {'measure': 'PGI-S (Patient Global Impression - Severity)', 'timeFrame': 'study endpoint, up to 10 weeks', 'description': 'Change from Baseline in PGI-S'}, {'measure': 'SDS (Sheehan Disability Scale)', 'timeFrame': 'study endpoint, up to 10 weeks', 'description': 'Change from Baseline in SDS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD (DSM-5 criteria)\n* Stable allowed medications with no planned changes from 30 days prior to screening through study participation\n* Willing to use highly effective birth control\n* Willing to comply with protocol visits and procedures\n\nExclusion Criteria:\n\n* Moderate to severe traumatic brain injury\n* Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders\n* Substance use disorder or alcohol use disorder within 6 months prior to screening\n* Psychotherapy or cognitive based therapy within 30 days prior to screening\n* Use of investigational drug within 30 days prior to screening\n* Prior participation in study of NYX-783, NYX-2925 or NYX-458.'}, 'identificationModule': {'nctId': 'NCT05181995', 'briefTitle': 'Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aptinyx'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': 'NYX-783-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mg NYX-783 QD', 'description': '50 mg NYX-783 QD', 'interventionNames': ['Drug: NYX-783']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo QD', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NYX-783', 'type': 'DRUG', 'description': 'NYX-783', 'armGroupLabels': ['50 mg NYX-783 QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 50 mg NYX-783', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Aptinyx Clinical Site', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Aptinyx Clinical Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Aptinyx Clinical Site', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 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