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Av-Ec2023

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.

Table of Contents

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.[1] 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.[1] 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.[1]

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.[1] The study is designed in two phases:

  1. Phase A: A 1-month randomized, placebo-controlled, double-blind interventional trial
  2. 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:[1]

  • 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:[1]

  • 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:[1]

  • 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.[1]

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.

Aspect Details
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

FAQ

  • What is Av-Ec2023 and what is it being studied for? Av-Ec2023, also known as Escholzia tablets, is a newly developed pharmaceutical product being studied for the treatment of insomnia in adults. The clinical trial aims to evaluate its effectiveness in improving sleep quality and assess its safety profile.
  • How long does the clinical trial last? The clinical trial has two phases: Phase A lasts for 1 month and is a randomized, placebo-controlled, double-blind study. Phase B is a 2-month prospective, single-arm study. In total, the trial lasts for 3 months.
  • Who can participate in this clinical trial? Participants must be adults aged 18-65 years, diagnosed with insomnia according to ICD-10 F51.0 criteria, have an Insomnia Severity Index (ISI) score greater than 7, and meet other specific inclusion criteria. However, there are several exclusion criteria, such as certain medical conditions or medication use, that may prevent participation.
  • What are the main objectives of the study? The main objective is to demonstrate the efficacy of Av-Ec2023 tablets in improving perceived sleep quality for insomnia treatment. Secondary objectives include assessing its effects on cognitive function, mood, anxiety, stress, happiness, satisfaction, and physiological sleep quantity.
  • How will the effectiveness of Av-Ec2023 be measured? The primary measure of effectiveness is the change in perceived sleep quality, assessed using the Insomnia Severity Index (ISI). Other measurements include changes in sleep quantity and quality through daily sleep diaries, actigraphy, questionnaires on daytime sleepiness, anxiety, mood, quality of life, and cognitive performance tests. The study will also analyze biological markers for stress and sleep readiness.

Ongoing Clinical Trials on Av-Ec2023

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

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Insomnia: A sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite having the opportunity for adequate sleep. In this study, it refers specifically to the condition classified as ICD-10 F51.0.
  • Placebo-controlled: A study design where some participants receive an inactive substance (placebo) instead of the actual drug being tested, allowing researchers to compare the true effects of the drug against no treatment.
  • Double-blind: A study method where neither the participants nor the researchers directly involved know who is receiving the actual treatment and who is receiving a placebo, reducing potential bias in the results.
  • Insomnia Severity Index (ISI): A clinical assessment tool used to measure the severity of insomnia symptoms. In this study, participants must have a score greater than 7 to be eligible.
  • Actigraphy: A non-invasive method of monitoring human rest/activity cycles, typically using a wearable device to measure movement and estimate sleep patterns.
  • Cognitive function: Mental abilities including memory, attention, problem-solving, and decision-making. The study aims to assess how Av-Ec2023 might affect these abilities.
  • Biomarker: A measurable indicator of a biological state or condition. In this study, biomarkers for stress and sleep readiness will be measured through saliva samples.
  • Polysomnography (PSG): A comprehensive sleep study that records brain waves, blood oxygen levels, heart rate, breathing, and eye and leg movements during sleep.
  • Epworth Sleepiness Scale (ESS): A questionnaire used to measure a person's general level of daytime sleepiness or average sleep propensity in daily life.
  • State-Trait Anxiety Inventory (STAI): A psychological inventory assessing anxiety levels, with the STAI-X1 specifically measuring state anxiety, or anxiety experienced in the present moment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-av-ec2023-tablets-for-adults-with-insomnia/