Last updated: September 5, 2023
Sponsor: EMS
Overall Status: Active - Not Recruiting
Phase
3
Condition
Insomnia
Restless Leg Syndrome
Treatment
Sublingual Tablet
Clinical Study ID
NCT05456152
EMS0222- SERENA
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability to confirm voluntary participation and agree to all trial purposes by signingand dating the informed consent forms;
- Age between 18 to 64 years;
- Participants diagnosed with chronic insomnia defined by difficulty in initiating ormaintaining sleep in the last 3 months for at least 3 nights a week according to DSM-Vcriteria and confirmed by polysomnography;
- Participants with difficulty in initiating or maintaining sleep parameters.
Exclusion
Exclusion Criteria:
- Participants with clinical or laboratory diagnose of non-treated hypothyroidism orhyperthyroidism, kidney or liver failure;
- Known hypersensitivity to any of the formula compounds;
- Participants with other sleep disorders according to the International ClassificationSleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadianrhythm sleep-wake disorders, parasomnias (including history of sleep-walking afterhypnotic use) and sleep related movement disorders;
- Participants using sedatives or hypnotic medications;
- Participants with current diagnosis of depression or anxiety according to theDiagnostic and Statistical Manual of Mental Disorders;
- Participants with history of drug and alcohol abuse in the past 2 years;
- Participants with current smoking habits during the night period;
- Participants who treated insomnia in the last 3 months;
- Participants who are pregnant, breastfeeding or planning to get pregnant or femaleparticipants with the potential to become pregnant who are not using a reliable methodof contraception;
- Any clinical and laboratory findings that, in the judgment of the investigator, mayinterfere with the safety of research participants;
- Participants with current or medical history of cancer in the last 5 years;
- Participants who participated in other research protocol in the last 12 months, unlessthe investigator judges that there may be a direct benefit to it.
Study Design
Total Participants: 358
Treatment Group(s): 1
Primary Treatment: Sublingual Tablet
Phase: 3
Study Start date:
June 01, 2024
Estimated Completion Date:
February 28, 2025
Connect with a study center
Investigational Site
São Paulo, SP
BrazilSite Not Available
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