Status:
WITHDRAWN
Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia
Lead Sponsor:
EMS
Conditions:
Insomnia
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03814135
Start Date
January 1 2021
End Date
March 1 2022
Last Update
April 1 2021
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