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

NCT03814135 | Withdrawn Phase 2 DMC

• 1 other identifier: EMS0518 - HIPNOS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insomnia

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  5 weeks

Study Arms (3)

HIPNOS 3

EXPERIMENTAL

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; Other: Hipnos 5 Placebo

HIPNOS 5

EXPERIMENTAL

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; Other: Hipnos 3 Placebo

HIPNOS Placebo

PLACEBO COMPARATOR

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

Other: Hipnos 5 Placebo; Other: Hipnos 3 Placebo

Interventions

Hipnos 3 DRUG

1 tablet, oral, once a day.

Also known as: EMS tablet

HIPNOS 3

Hipnos 5 DRUG

1 tablet, oral, once a day.

Also known as: EMS tablet

HIPNOS 5

Hipnos 5 Placebo OTHER

1 tablet, oral, once a day.

Also known as: Placebo

HIPNOS 3; HIPNOS Placebo

Hipnos 3 Placebo OTHER

1 tablet, oral, once a day.

Also known as: Placebo

HIPNOS 5; HIPNOS Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Duble-blind and double-dummy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 23, 2019
• Study Start: January 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03