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Not yet recruiting NCT07420816

Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Phase II Interventional Insomnia Insomnia Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APSTZD 1, APSTZD 2, APSTZD 3, APSTZD 4.
Who it may be relevant to
Registry conditions: Insomnia, Insomnia Chronic. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography [Time frame: Change from baseline after 2 weeks of treatment]
Secondary outcome measures (1)
  • Adverse events incidence and classification [Time frame: Through study completion, up to 6 weeks]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • UNIFAG - Casa Nossa Senhora da PAZ -ASF — Bragança Paulista

Identifiers

NCT: NCT07420816 · APS002/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗