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NOT YET RECRUITING
NCT07420816
PHASE2

Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Sponsor: Apsen Farmaceutica S.A.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-03-26

Completion Date

2027-09-23

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

DRUG

APSTZD 1

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

DRUG

APSTZD 2

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

DRUG

APSTZD 3

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

DRUG

APSTZD 4

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

DRUG

Stilnox CR®

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

DRUG

Placebo

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