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Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

NCT07420816 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-02-19

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • Apsen Farmaceutica S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2027-09-23
Completion
2027-09-23

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07420816 on ClinicalTrials.gov