drugset / Trial / NCT07521683

A Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia

NCT07521683 ↗

Phase 2 Enrolling by invitation 150 enrolled NeuShen Therapeutics
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to preliminarily evaluate the efficacy and safety of NS-136 in patients with schizophrenia. The study consists of a screening period, baseline period, treatment period, and follow-up period, with the screening period lasting up to 21 days. Eligible subjects will be randomized in a 1:1:1 ratio to the 80 mg (QD) group, 120 mg (QD) group, or placebo group. The study drug treatment will last for 5 weeks, followed by a 2-week safety follow-up after completion of the study.

Timeline

Start
2025-10-20
Primary completion
2026-11
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NS-136 Unknown 80 mg —
Subject NS-136 Unknown 120 mg —

Indications