In short
This article discusses a clinical trial investigating the use of Av-Ec2023 tablets, also known as Escholzia tablets, for treating insomnia in adults. The study aims to assess the effectiveness of this newly developed pharmaceutical product in improving sleep quality and its overall safety profile. The trial is designed as a biphasic study, including a randomized, placebo-controlled phase followed by a prospective, single-arm phase, to thoroughly evaluate the drug's performance in addressing insomnia symptoms.
At a glance
- Drug Name
- Av-Ec2023 (Escholzia tablets)
- Condition Treated
- Insomnia (ICD-10 F51.0)
- Study Design
- Biphasic: 1-month randomized, placebo-controlled, double-blind phase (A) followed by 2-month prospective, single-arm phase (B)
- Primary Objectives
- Efficacy on perceived sleep quality and safety profile
- Key Inclusion Criteria
- Adults 18-65 years, diagnosed insomnia, ISI score > 7
- Primary Endpoints
- Change in ISI score (Phase A), Safety and tolerability (Phase B)
- Secondary Endpoints
- Changes in sleep quantity/quality, daytime sleepiness, anxiety, mood, quality of life, cognitive performance, stress biomarkers
What is AV-EC2023?
AV-EC2023 is a new medication being developed to treat insomnia. It comes in the form of tablets and is currently undergoing clinical trials to test its effectiveness and safety. The drug is also known by the name "Escholzia tablets," which may be derived from the plant Eschscholzia californica, commonly known as California poppy.
Medical Condition Treated
AV-EC2023 is specifically being studied for the treatment of insomnia, which is classified under the medical code ICD-10 F51.0. Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite having the opportunity to sleep. This condition can significantly impact a person's quality of life, affecting their mood, cognitive function, and overall well-being.
How It Works
While the exact mechanism of action is not provided in the clinical trial information, AV-EC2023 is likely designed to improve sleep quality and quantity. It may work by influencing sleep-wake cycles or addressing factors that contribute to insomnia. The medication is taken orally, suggesting it works systemically to affect sleep patterns.
Clinical Trial Information
AV-EC2023 is currently being studied in a Phase III clinical trial. This is considered a therapeutic confirmatory trial, which means it aims to confirm the effectiveness and safety of the drug for treating insomnia. The study is designed in two phases:
- Phase A: A 1-month randomized, placebo-controlled, double-blind interventional trial
- Phase B: A 2-month prospective, single-arm interventional trial
This design allows researchers to compare the drug's effects against a placebo and then observe its long-term effects and safety.
Who Can Participate?
The study is looking for participants who meet specific criteria, including:
- Adults aged 18-65 years
- Diagnosed with insomnia (ICD-10 F51.0)
- Have an Insomnia Severity Index (ISI) score greater than 7
- Typically go to bed between 9 PM and midnight
There are also several exclusion criteria, such as certain medical conditions, medication use, or lifestyle factors that might interfere with the study results or pose risks to participants.
What to Expect During the Study
Participants in the study will be asked to:
- Take the AV-EC2023 tablets as directed
- Complete daily e-diaries about their sleep
- Wear an actigraphy device (a wearable that measures sleep patterns)
- Provide saliva samples for analysis
- Complete various questionnaires about sleep quality, mood, anxiety, and quality of life
- Undergo cognitive performance tests
- Possibly use a polysomnography (PSG) device, which is a comprehensive sleep study tool
Potential Benefits
The study aims to evaluate several potential benefits of AV-EC2023, including:
- Improved sleep quality and quantity
- Reduced daytime sleepiness
- Better mood and reduced anxiety
- Enhanced cognitive function
- Improved overall quality of life
- Increased happiness and satisfaction
Safety Considerations
As with any new medication, safety is a primary concern. The study will closely monitor participants for any side effects or adverse reactions. People with certain conditions or taking specific medications may not be eligible to participate to ensure their safety.
It's important to note that individuals with hypersensitivity to plants from the poppy family or any of the ingredients in AV-EC2023 should not take this medication.