Stopped: The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Number of Participants With Serious TEAE
Timeframe: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Timeframe: Baseline (current study) up to 52 weeks
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
Timeframe: Baseline (current study) up to 52 weeks
Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding
Timeframe: Baseline (current study), Week 52
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Timeframe: Baseline (current study) up to 52 weeks
Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64
Timeframe: Baseline (current study), Week 64
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52
Timeframe: Baseline (current study), Week 52
Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52
Timeframe: Baseline (current study), Week 52