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Study on the Effectiveness and Safety of AV-EC2023 Tablets for Adults with Insomnia

Investigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for insomnia, a condition where individuals have trouble falling asleep or staying asleep. The treatment being tested is called Escholzia tablets, which is a newly developed medication. The study will compare the effects of these tablets to a placebo tablet that looks and feels the same but does not contain any active ingredients.

The purpose of the study is to evaluate how well the Escholzia tablets improve sleep quality and how safe they are for use. The study is divided into two phases. In the first phase, participants will be randomly assigned to receive either the Escholzia tablets or the placebo for one month. This phase is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. In the second phase, all participants will receive the Escholzia tablets for an additional two months to further assess the treatment's safety and effectiveness.

Throughout the study, participants will be asked to keep a daily sleep diary and may wear a device to monitor their sleep patterns. The study will also look at changes in daytime sleepiness, mood, and overall quality of life. Additionally, some participants may provide saliva samples to measure levels of certain hormones related to stress and sleep. The study aims to provide valuable information on how Escholzia tablets can help people with insomnia improve their sleep and overall well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Phase A: Initial Treatment
The first phase of the trial lasts for one month. During this time, participants will receive either the AV-EC2023 tablet or a placebo. The tablet is taken orally once a day.
The purpose of this phase is to evaluate the effectiveness of the AV-EC2023 tablet in improving sleep quality. Participants will not know if they are receiving the active tablet or the placebo, ensuring unbiased results.
Step 2
Daily Monitoring
Participants are required to maintain a daily sleep diary to record their sleep patterns and quality. This helps in assessing changes in perceived sleep quality.
Participants will also wear a device called an actigraph, which measures sleep quantity and patterns.
Step 3
Phase B: Extended Treatment
After completing Phase A, participants enter Phase B, which lasts for two months. In this phase, all participants receive the AV-EC2023 tablet.
The focus of this phase is to assess the safety and tolerability of the treatment over a longer period.
Step 4
Regular Assessments
Throughout the trial, participants will undergo various assessments to measure changes in sleep quality, daytime sleepiness, anxiety, mood, and overall quality of life.
These assessments include questionnaires like the Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and others.
Step 5
Biomarker Collection
Participants will provide saliva samples to measure levels of cortisol and melatonin, which are indicators of stress and sleep readiness, respectively.
These samples are collected in the evening and stored appropriately for analysis.
Step 6
Completion of Trial
The trial is expected to conclude by March 31, 2025. Upon completion, participants will have contributed valuable data to assess the efficacy and safety of the AV-EC2023 tablet for treating insomnia.

Who can join the trial?

7 criteria

Provide a voluntary, written, informed consent to participate in the study. This means you agree to join the study after understanding what it involves.
Be a male or female aged between 18 and 65 years, including those ages.
Have a diagnosis of insomnia according to ICD-10 F51.0. Insomnia is a condition where you have trouble sleeping.
Have an ISI total score greater than 7. ISI stands for Insomnia Severity Index, which is a way to measure how severe your insomnia is.
Have a usual bedtime between 9 pm and midnight.
Have easy access to the internet to fill out a daily e-diary. An e-diary is an electronic diary where you record information about your sleep.
Have freezing capacities available for storing saliva samples. This means you need a way to keep saliva samples cold.

Who cannot join the trial?

9 criteria

Patients who are not diagnosed with insomnia. Insomnia is a condition where a person has trouble sleeping.
Patients who are under the age of 18.
Patients who are part of a vulnerable population. This means people who might need special protection or care.
Patients who are not able to follow the study procedures or instructions.
Patients who have other medical conditions that might interfere with the study.
Patients who are taking medications that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of substance abuse. This means using drugs or alcohol in a way that is harmful.
Patients who have participated in another clinical trial recently.

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Investigated drugs

Escholzia tablets are being studied for their effectiveness and safety in treating adults with insomnia. The trial aims to determine how well these tablets improve sleep quality and assess their safety for individuals diagnosed with insomnia.

Av-Ec2023

What is already known about the treatment

Escholzia tablets – This medication is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness and safety in treating insomnia. The trials are designed to assess its impact on sleep quality and overall safety. Escholzia tablets are primarily indicated for individuals diagnosed with insomnia, as classified under the ICD-10 F51.0 code. The medication works by interacting with certain receptors in the brain to promote relaxation and improve sleep patterns. It is classified pharmacologically as a sedative-hypnotic agent.

Investigated diseases

Insomnia – Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or waking up too early and not being able to return to sleep. It can lead to daytime fatigue, mood disturbances, and difficulty concentrating. The condition can be acute, lasting a few days or weeks, or chronic, persisting for a month or longer. Insomnia can be caused by stress, irregular sleep schedules, poor sleeping habits, mental health disorders, or other medical conditions. It often results in a reduced quality of life due to the impact on daily functioning. The severity and duration of insomnia can vary widely among individuals.