Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia

Phase 2

Withdrawn

• Conditions: Insomnia
• Interventions: Drug: Hipnos 3; Drug: Hipnos 5; Other: Hipnos 3 Placebo; Other: Hipnos 5 Placebo

• Registration Number: NCT03814135
• Lead Sponsor: EMS

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Study Start: 2021-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-02
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participants aged 50 years or more;
• Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
• Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.

Exclusion Criteria

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Known hypersensitivity to the formula components used during the clinical trial;
• Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
• History of hepatic impairment;
• Current smoking;
• Pregnancy or risk of pregnancy and lactating patients;
• History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
• Diagnosis of clinical diseases that interfere with sleep;
• Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
• Participation in clinical trial in the year prior to this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIPNOS 5	Hipnos 3 Placebo	The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.
HIPNOS 3	Hipnos 3	The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.
HIPNOS 3	Hipnos 5 Placebo	The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.
HIPNOS 5	Hipnos 5	The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.
HIPNOS Placebo	Hipnos 5 Placebo	The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.
HIPNOS Placebo	Hipnos 3 Placebo	The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.

Primary Outcome Measures

Name	Time	Method
Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	5 weeks