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

March 30, 2021 updated by: EMS

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Hipnos 3
1 tablet, oral, once a day.
Other Names:
  • EMS tablet
Other: Hipnos 5 Placebo
1 tablet, oral, once a day.
Other Names:
  • Placebo
Experimental: 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.
Drug: Hipnos 5
1 tablet, oral, once a day.
Other Names:
  • EMS tablet
Other: Hipnos 3 Placebo
1 tablet, oral, once a day.
Other Names:
  • Placebo
Placebo Comparator: HIPNOS Placebo
The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.
Other: Hipnos 5 Placebo
1 tablet, oral, once a day.
Other Names:
  • Placebo
Other: Hipnos 3 Placebo
1 tablet, oral, once a day.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study.
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0518 - HIPNOS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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