EMPOWER AUD Pivotal Trial

Status Recruiting

Clinical Trial Summary

Multi-site, double-blinded, prospective, randomized, sham-controlled study

Clinical Trial Description

To evaluate the safety and effectiveness of the Empower Neuromodulation System in alcohol use disorder (AUD) patients. The primary safety endpoint will be device-related serious adverse events. The primary effectiveness endpoint will be responder rate at 12 weeks, where a responder is defined as a subject who experiences at least a one level reduction in the WHO risk level for daily alcohol consumption from Baseline to Week 12 as measured via the 28-day Timeline Follow-back (TLFB). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05948605
Study type	Interventional
Source	Theranova, L.L.C.
Contact	Aaron Miller
Phone	4159268616
Email	ClinicalStudy@TheraNova.com
Status	Recruiting
Phase	N/A
Start date	December 1, 2023
Completion date	May 1, 2025

View Details

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