RecruitingPhase 2NCT07420816

Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder


Sponsor

Apsen Farmaceutica S.A.

Enrollment

222 participants

Start Date

Aug 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called APSTZD 1, a drug called APSTZD 2, and others for people with insomnia and insomnia chronic. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPSTZD 1

APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1

DRUGAPSTZD 2

APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1

DRUGAPSTZD 3

APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1

DRUGAPSTZD 4

APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1

DRUGStilnox CR®

Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4

DRUGPlacebo

placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1


Locations(1)

UNIFAG - Casa Nossa Senhora da PAZ -ASF

Bragança Paulista, São Paulo, Brazil

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NCT07420816


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