NCT07420816

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Apsen Farmaceutica S.A. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Insomnia
• Insomnia Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-26
• Primary completion: 2027-09-23
• Completion: 2027-09-23
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Brazil