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Tasipimidine

Tasipimidine is a new drug being studied for its potential to help people with insomnia disorder. This article discusses recent clinical trials that are testing how well tasipimidine works and how safe it is for patients who have trouble sleeping. We’ll look at the study’s design, who can participate, and what the researchers hope to learn about this new treatment option.

Table of Contents

What is Tasipimidine?

Tasipimidine (also known as ODM-105) is a new medication being studied for the treatment of insomnia disorder. It is currently undergoing clinical trials to evaluate its effectiveness and safety[1]. Tasipimidine is administered as an oral solution, which means it’s a liquid that you drink[1].

Medical Condition Treated

Tasipimidine is being developed to treat insomnia disorder. Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite having the opportunity to sleep. This can lead to daytime fatigue, mood disturbances, and impaired performance in daily activities[1].

How Tasipimidine Works

While the exact mechanism of action is not fully described in the provided information, tasipimidine is likely to work on specific receptors in the brain that are involved in regulating sleep. It’s important to note that tasipimidine is a new substance that hasn’t been previously authorized for human use, which is why it’s undergoing clinical trials[1].

Clinical Trial Details

The clinical trial for tasipimidine is a Phase IIa study, which means it’s in the early stages of testing in humans. Here are some key details about the trial:

  • It’s a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either tasipimidine or a placebo, and neither the participants nor the researchers know who is receiving which[1].
  • The study is dose-escalating, meaning different groups of participants will receive increasing doses of the medication to determine the most effective and safe dose[1].
  • The study takes place in a sleep laboratory setting, where participants’ sleep can be closely monitored[1].

Eligibility Criteria

To participate in this study, individuals must meet certain criteria. Some key inclusion criteria are:

  • Age between 18 and 65 years[1].
  • Diagnosed with insomnia disorder according to DSM-5-TR® criteria[1].
  • History of taking 30 minutes or more to fall asleep and sleeping 6 hours or less, at least 3 nights per week for at least 3 months[1].
  • An Insomnia Severity Index© (ISI©) score of 15 or higher. This is a clinical tool used to measure the severity of insomnia symptoms[1].

There are also several exclusion criteria, such as certain medical conditions or use of specific medications, that would prevent someone from participating in the study[1].

Potential Benefits

The main goals of the tasipimidine study are to evaluate its effectiveness in treating insomnia. Specifically, the researchers are looking at:

  • Wake after sleep onset (WASO): This measures how much time a person spends awake after initially falling asleep[1].
  • Latency to persistent sleep (LPS): This measures how long it takes a person to fall into a steady state of sleep[1].

If successful, tasipimidine could potentially help people with insomnia fall asleep faster and stay asleep longer.

Safety Considerations

As with any new medication, safety is a primary concern. The study is closely monitoring several safety aspects, including:

  • Adverse events (side effects)[1]
  • Blood pressure changes[1]
  • Morning sleepiness[1]
  • Changes in laboratory tests[1]

It’s important to note that as tasipimidine is still in the early stages of testing, not all potential side effects may be known. The study is designed to carefully monitor participants and gather this important safety information.

Aspect Details
Drug Name Tasipimidine
Condition Studied Insomnia disorder
Study Design Randomized, double-blind, placebo-controlled, dose-escalation, multisite, phase 2a study
Main Objectives Evaluate efficacy, safety, tolerability, and pharmacokinetics of tasipimidine
Primary Endpoints Wake After Sleep Onset (WASO) and Latency to Persistent Sleep (LPS)
Key Inclusion Criteria Age 18-65, diagnosed insomnia disorder, specific sleep difficulties for at least 3 months
Key Exclusion Criteria Sleep-related breathing disorders, unstable psychiatric conditions, significant medical conditions
Dosage Form Oral solution

FAQ

  • What is tasipimidine and what is it being studied for? Tasipimidine is a new drug being investigated as a potential treatment for insomnia disorder. It's currently undergoing clinical trials to evaluate its effectiveness and safety in helping people who have difficulty falling asleep or staying asleep.
  • How is the clinical trial for tasipimidine designed? The trial is a randomized, double-blind, placebo-controlled, dose-escalation study. This means that participants are randomly assigned to receive either tasipimidine or a placebo, neither the participants nor the researchers know who is receiving which, and different doses of the drug are being tested in sequence.
  • Who can participate in the tasipimidine clinical trial? Participants must be between 18 and 65 years old, have been diagnosed with insomnia disorder, and meet specific sleep criteria. They should have a history of taking at least 30 minutes to fall asleep and sleeping 6 hours or less for at least 3 nights a week over 3 months.
  • What are the main goals of the tasipimidine clinical trial? The main objectives are to evaluate the effectiveness of tasipimidine in treating insomnia disorder, assess its safety and tolerability, study how the drug moves through the body (pharmacokinetics), and determine the relationship between the drug's concentration in the body and its effects (pharmacodynamics).
  • How is the effectiveness of tasipimidine being measured? The primary measures of effectiveness are 'Wake After Sleep Onset' (WASO) and 'Latency to Persistent Sleep' (LPS), both assessed using polysomnography (PSG). These measurements help determine how well the drug helps people stay asleep and how quickly they fall asleep.

Ongoing Clinical Trials on Tasipimidine

  • Study on the Effects of Tasipimidine for Patients with Insomnia Disorder

    Not recruiting

    2 1
    Investigated drugs:
    Finland Germany Poland

Glossary

  • Insomnia disorder: A sleep condition where a person has difficulty falling asleep, staying asleep, or both, despite having the opportunity for adequate sleep. This results in poor sleep quality and can affect daytime functioning.
  • Polysomnography (PSG): A comprehensive sleep study that records brain waves, blood oxygen levels, heart rate, breathing, and eye and leg movements during sleep. It's used to diagnose sleep disorders and measure sleep quality.
  • Wake After Sleep Onset (WASO): The amount of time a person spends awake after initially falling asleep. It's a measure of sleep quality and continuity.
  • Latency to Persistent Sleep (LPS): The time it takes from the start of a sleep period to the beginning of sustained sleep. It's a measure of how quickly a person falls asleep.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Double-blind study: A research design where neither the participants nor the researchers directly involved know who is receiving the treatment and who is receiving a placebo. This helps prevent bias in the study results.
  • Placebo: An inactive substance that looks like the drug being tested but has no therapeutic effect. It's used as a control in clinical trials to help determine the true effects of the drug being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-tasipimidine-for-patients-with-insomnia-disorder/