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Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

RecruitingPhase 2Ages 18 Years - 64 YearsAllApsen Farmaceutica S.A.
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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;
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What it tests

  • APSTZD 1
  • APSTZD 2
  • APSTZD 3
  • APSTZD 4
  • Stilnox CR®
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Where

1 site
UNIFAG - Casa Nossa Senhora da PAZ -ASF
Bragança Paulista, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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