Health TrialsbyHealthPanel

Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

ConditionsInsomniaInsomnia Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorApsen Farmaceutica S.A.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

222 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: APSTZD 1Experimental treatment 1 intervention
Group B: APSTZD 2Experimental treatment 1 intervention
Group C: APSTZD 3Experimental treatment 1 intervention
Group D: APSTZD 4Experimental treatment 1 intervention
Group E: Stilnox CR®Active comparator 1 intervention
Group F: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Apsen Farmaceutica S.A.

Lead sponsor

Source ClinicalTrials.gov
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