Study on the Effects of Tasipimidine for Patients with Insomnia Disorder

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What is this study about?

This clinical trial is focused on studying insomnia disorder, a condition where individuals have trouble falling asleep or staying asleep. The treatment being tested is called ODM-105, which is an oral solution containing the active substance tasipimidine. The trial will also use an ODM-105 placebo oral solution for comparison purposes.

The purpose of the study is to evaluate how effective tasipimidine is in helping patients with insomnia disorder. Participants in the study will take the medication at bedtime for three consecutive nights. Throughout the study, researchers will monitor various aspects of sleep, such as how long it takes to fall asleep and how often participants wake up during the night. The study will also keep track of any side effects and changes in vital signs like heart rate and blood pressure.

Participants will be asked to report their experiences and any changes in their sleep patterns. The study aims to provide valuable information on the potential benefits and safety of tasipimidine for treating insomnia disorder.

1 joining the study

Upon joining the study, ensure that the informed consent form is signed. This confirms understanding and agreement to participate in the trial.

Eligibility is confirmed based on criteria such as age between 18 and 65 years, a diagnosis of insomnia disorder, and specific sleep patterns.

2 initial assessment

An initial assessment is conducted to evaluate sleep patterns. This includes a polysomnography (PSG) test, which monitors sleep to measure how long it takes to fall asleep and total sleep time.

The assessment ensures that the criteria for sleep latency and total sleep time are met.

3 medication administration

The study involves taking an oral solution called ODM-105, which contains the active substance tasipimidine. A placebo solution may also be administered.

The medication is taken as a 0.3 mg/ml oral solution at bedtime for three consecutive nights.

4 monitoring and evaluation

Throughout the trial, sleep is monitored using polysomnography (PSG) to assess wakefulness after sleep onset and latency to persistent sleep.

Additional evaluations include monitoring for any adverse events, heart rate, blood pressure, and morning sleepiness.

5 completion of the trial

After completing the medication phase, a final assessment is conducted to evaluate the effects of the treatment.

The study aims to determine the efficacy and tolerability of tasipimidine in treating insomnia disorder.

Who Can Join the Study?

Signed informed consent for participation in the study.
Male or female participants aged between 18 and 65 years at the screening visit.
Have insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition Text Revision (DSM-5-TR®).
Have a self-reported history of taking 30 minutes or more to fall asleep and sleeping 6 hours or less on at least 3 nights per week for at least 3 months before the screening.
Have an Insomnia Severity Index (ISI©) score of 15 or higher. The ISI is a questionnaire used to measure the severity of insomnia.
Usual bedtime is between 9:00 PM and 2:00 AM.
Regular time spent in bed is between 6 and 9 hours.
Meet specific sleep criteria during the 2 screening nights using polysomnography (PSG), a type of sleep study:
- Average time to fall into a deep sleep (latency to persistent sleep) is 25 minutes or more (with neither of the 2 nights being less than 15 minutes).
- Average total sleep time is 6 hours or less.
If sexually active and not permanently sterilized, female participants with a fertile male partner and male participants with female partners who can become pregnant must use a highly effective form of contraception. Women who are postmenopausal (1 year since their last menstrual cycle) are considered not to be able to have children and can be included.

Who Cannot Join the Study?

Patients with any other sleep disorders besides insomnia disorder cannot participate. Insomnia disorder is a condition where a person has trouble falling asleep or staying asleep.
Patients who are currently using medications that affect sleep or wakefulness cannot participate.
Patients with a history of substance abuse or dependence in the past year cannot participate. Substance abuse refers to the harmful use of substances like drugs or alcohol.
Patients with any serious medical conditions that are not stable cannot participate. A serious medical condition is one that requires ongoing medical attention and could affect the study.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with known allergies to the study medication or similar drugs cannot participate.
Patients with a history of psychiatric disorders that are not well-controlled cannot participate. Psychiatric disorders are mental health conditions like depression or anxiety.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Klinische Forschung Karlsruhe GmbH	Karlsruhe	Germany
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Suomen Terveystalo Oy	Helsinki	Finland
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
FutureMeds GmbH	Berlin	Germany
Klinische Forschung Hannover-Mitte GmbH	Hanover	Germany
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
Klinische Forschung Hamburg GmbH	Hamburg	Germany
Specjalistyczne Gabinety Sp. z o.o.	Cracow	Poland
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Siteworks GmbH	Hanover	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Turku University Hospital	Turku	Finland
Pratia S.A.	Skorzewo	Poland
Klinische Forschung Berlin GbR	Berlin	Germany
Advanced Sleep Research GmbH	Berlin	Germany
HELIOS Kliniken Schwerin GmbH	Schwerin	Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Cvuzvcj Bpgtz Kdanxgzmxal Poegkrsa Sck z ovlo	Gdansk	Poland
Ktpbgpxmw Ftocrermd Dqssiij Gclm	Dresden	Germany
Lefamzwvwrmrc Ayah Kdagxr	Kuopio	Finland
Llvpmkmlnrfit Affx Kfvshv	Helsinki	Finland
Ialvopfp Bvgfto Gygz	Berlin	Germany
Snwzlp Tcelalhizsd Or	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	01.05.2023
Germany	Not recruiting	01.05.2023
Poland	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Tasipimidine

Tasipimidine is a medication being studied for its potential to help people who have trouble sleeping, a condition known as insomnia disorder. This medication is taken at bedtime, and the trial is looking at how well it works and how well people can tolerate it after taking it for three nights in a row. The goal is to see if tasipimidine can help improve sleep quality and duration for those who struggle with insomnia.

Insomnia disorder – Insomnia disorder is a condition characterized by difficulty falling asleep, staying asleep, or waking up too early and not being able to return to sleep. It often leads to dissatisfaction with sleep quality and can result in daytime fatigue, mood disturbances, and impaired cognitive function. The disorder can be acute, lasting a few days to weeks, or chronic, persisting for a month or longer. It may occur independently or be associated with other medical or psychiatric conditions. The progression of insomnia disorder can vary, with some individuals experiencing intermittent episodes, while others may have persistent symptoms. Factors such as stress, lifestyle, and environmental changes can influence the severity and frequency of insomnia episodes.

Trial ID:

2022-502483-21-00

Protocol code:

3110012

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Tasipimidine for Patients with Insomnia Disorder

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