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NCT Number: NCT07420816

Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

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

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Key information

Conditions

Insomnia Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UNIFAG - Casa Nossa Senhora da PAZ -ASF

Bragança Paulista, São Paulo, 12916-900, Brazil

Location contact

Rafaella Santos Dantas Beltrame

CONTACT

[email protected]

+55(35)98833-9715

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged between 18 and 64 years;
  • Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;
  • Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).

Exclusion criteria

  • Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;
  • Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
  • Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;
  • Participants diagnosed with severe liver failure;

Treatment and study plan

APSTZD 1

Drug

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

APSTZD 2

Drug

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

APSTZD 3

Drug

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

APSTZD 4

Drug

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

Stilnox CR®

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography

    Time frame: Change from baseline after 2 weeks of treatment

Secondary outcomes

  1. Adverse events incidence and classification

    Time frame: Through study completion, up to 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fernanda Martinez Scalzaretto

CONTACT

[email protected]

+551156448200

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study 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

Acronym: TINA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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