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

Primary Purpose

Insomnia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Hipnos 3

Hipnos 5

Hipnos 5 Placebo

Hipnos 3 Placebo

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

HIPNOS 3

HIPNOS 5

HIPNOS Placebo

Arm Description

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.

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.

The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.

Outcomes

Primary Outcome Measures

Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.

Secondary Outcome Measures

Incidence and severity of adverse events recorded during the study.

Full Information

NCT ID

NCT03814135

First Posted

January 22, 2019

Last Updated

March 30, 2021

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT03814135

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor decision

Study Start Date

January 2021 (Anticipated)

Primary Completion Date

February 2022 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Duble-blind and double-dummy

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIPNOS 3

Arm Type

Experimental

Arm Description

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.

Arm Title

HIPNOS 5

Arm Type

Experimental

Arm Description

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.

Arm Title

HIPNOS Placebo

Arm Type

Placebo Comparator

Arm Description

The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.

Intervention Type

Drug

Intervention Name(s)

Hipnos 3

Other Intervention Name(s)

EMS tablet

Intervention Description

1 tablet, oral, once a day.

Intervention Type

Drug

Intervention Name(s)

Hipnos 5

Other Intervention Name(s)

EMS tablet

Intervention Description

1 tablet, oral, once a day.

Intervention Type

Other

Intervention Name(s)

Hipnos 5 Placebo

Other Intervention Name(s)

Placebo

Intervention Description

1 tablet, oral, once a day.

Intervention Type

Other

Intervention Name(s)

Hipnos 3 Placebo

Other Intervention Name(s)

Placebo

Intervention Description

1 tablet, oral, once a day.

Primary Outcome Measure Information:

Title

Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Incidence and severity of adverse events recorded during the study.

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

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