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

EMS

Status and phase: Withdrawn; Phase 2

Conditions: Insomnia

Treatments: Other: Hipnos 5 Placebo; Other: Hipnos 3 Placebo; Drug: Hipnos 3; Drug: Hipnos 5

Study type: Interventional

Funder types: Industry

Identifiers

NCT03814135

EMS0518 - HIPNOS

Details and patient eligibility

About

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

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

HIPNOS 3

Experimental group

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.

Treatment:

Drug: Hipnos 3

Other: Hipnos 5 Placebo

HIPNOS 5

Experimental group

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.

Treatment:

Drug: Hipnos 5

Other: Hipnos 3 Placebo

HIPNOS Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Hipnos 3 Placebo

Other: Hipnos 5 Placebo