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

Insomnia Clinical Trial

Official title:

Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03814135
• Other study ID #: EMS0518 - HIPNOS
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Hipnos 3
1 tablet, oral, once a day.
• Hipnos 5
1 tablet, oral, once a day.

Other:
• Hipnos 5 Placebo
1 tablet, oral, once a day.
• Hipnos 3 Placebo
1 tablet, oral, once a day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.		4 weeks
Secondary	Incidence and severity of adverse events recorded during the study.		5 weeks