drugset / Trial / NCT06011577

Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

NCT06011577 ↗

Phase 3 Terminated 27 enrolled Levomecor Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

Timeline

Start
2023-08-17
Primary completion
2024-12-19
Completion
2024-12-19

Outcome

Outcome not reported

Stopped: “Study REL-1017-304 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation conducted in study REL-1017-302. Safety assessments were performed in both studies in accordance with the study protocols”

Drugs

EvaluationDrugModalityDoseRoute
Subject Esmethadone Small molecule 25 mg Oral