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AD04

Phase 3

Alcohol Use Disorder | Small molecule | Psychiatry |Adial Pharmaceuticals, Inc|Last Updated: Apr 17, 2024

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment302
FDA Designations
No designations recorded
Clinical trial landscape

AD04 · 1 trial · 1 indication

Phase 3 1
NCT04101227Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter PolymorphismsAlcohol Use Disorder
COMPLETED302 Analytics
PHASE3COMPLETED
Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms
Alcohol Use Disorder
NCT04101227302
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Study Endpoints
Primary Endpoints
Change from baseline in the percentage of monthly heavy drinking days (PHDD)
Weeks 16 to 24

Change from baseline in the percentage of monthly HDDs, where (heavy) drinking is defined as the consumption of ≥ 60 g alcohol/day (if male) or ≥ 40 g alcohol/day (if female).

Secondary Endpoints
Change from baseline in the primary efficacy endpoint at each study month
Weeks 4, 8, 12, 16, 20, and 24
Change from baseline in AUD symptoms and clinical status
Weeks 12 and 24
Change from baseline in Drinking Risk Levels (DRL), 1-level shift
Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment ArmEXPERIMENTALAD04 (ondansetron)
Placebo ArmPLACEBO_COMPARATORMatching Placebo
Interventions
NameTypeDescription
AD04 (ondansetron)DRUGAD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID)
Matching placeboDRUGMatching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID)
Companion Diagnostic for Genetic TestingDEVICECompanion Diagnostic for Genetic Testing
Brief Psychological CounselingBEHAVIORALBrief Psychological Counseling
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: 1. The subject has signed the Informed Consent Form. 2. The subject has breath alcohol concentration (BAC) of 0.00% at the Screening and \< 0.02 % at the Baseline visit. 3. The subject has moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Me...

Countries:BulgariaCroatiaEstoniaFinlandLatviaPolandSweden
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