Ongoing Clinical Trials for Circadian Rhythm Sleep Disorder
This article provides information about ongoing clinical trials for Circadian Rhythm Sleep Disorder, a condition affecting the body’s internal clock and sleep-wake patterns. Currently, there is one active trial investigating a medication called tasimelteon for patients with Delayed Sleep-Wake Phase Disorder, a specific type of circadian rhythm disorder. The trial is being conducted in Austria and Germany.
Clinical trial locations
- Austria
- Germany
Study on the Effects of Tasimelteon for Patients with Delayed Sleep-Wake Phase Disorder
This clinical trial focuses on Delayed Sleep-Wake Phase Disorder, a specific type of circadian rhythm sleep disorder. In this condition, the body’s internal clock is shifted, making it difficult for people to fall asleep and wake up at conventional times. The study investigates whether tasimelteon, a medication that targets melatonin receptors in the brain, can help regulate sleep-wake patterns and improve sleep onset in affected individuals.
Main inclusion criteria:
- Adults aged 18 to 75 years with a confirmed diagnosis of Delayed Sleep-Wake Phase Disorder according to international sleep disorder classification
- Sleep start time of midnight or later on at least 5 out of 7 days during screening
- Sleep start time at least 2 hours later than desired bedtime on at least 5 out of 7 days
- Body Mass Index between 18 and 35
- Good general health based on medical history and tests
- Ability to maintain a sleep diary with at least 80% completion during screening
- Willingness to follow study rules, including keeping a fixed sleep schedule and attending clinic visits
- For women of childbearing potential, use of effective birth control and negative pregnancy tests
Main exclusion criteria:
- Not having a diagnosis of Delayed Sleep-Wake Phase Disorder
- Unable to take daily oral medication
- Unable to maintain a sleep diary throughout the study
- Outside the specified age range
- Unwilling or unable to follow study procedures
- Other medical conditions that might interfere with study results
- Currently participating in another clinical trial
- Known allergy or adverse reaction to the study medication
Focus and goal of the trial:
The study is designed as a double-blind, placebo-controlled trial lasting 28 days. Participants are randomly assigned to receive either tasimelteon 20 mg or a placebo capsule that looks identical to the medication. The main goal is to evaluate how daily dosing of tasimelteon affects the time it takes to fall asleep compared to placebo.
During the treatment phase, participants keep a sleep diary to record their sleep patterns. The study also uses actigraphy, which involves wearing a device that monitors movement to gather objective information about sleep. Some participants may provide saliva samples to measure changes in their body’s internal clock.
The trial assesses various aspects of sleep including sleep onset time, total sleep time, and any sleep disturbances. Researchers also examine how the medication affects the circadian phase, which is the timing of the body’s internal clock that regulates sleep-wake cycles. Safety and tolerability of tasimelteon are monitored throughout the study to ensure participant well-being.
Investigational drug:
Tasimelteon is the medication being tested in this trial. It is taken orally as a 20 mg capsule once daily. Tasimelteon works by targeting melatonin receptors in the brain, which play a role in regulating the sleep-wake cycle. It is classified as a melatonin receptor agonist, meaning it activates these receptors to help align the body’s internal clock with the desired sleep schedule. The study aims to determine whether tasimelteon can help people with Delayed Sleep-Wake Phase Disorder fall asleep more easily and at a more typical time.
Summary
Currently, there is one ongoing clinical trial for Circadian Rhythm Sleep Disorder, specifically targeting Delayed Sleep-Wake Phase Disorder. The trial is being conducted in two European countries: Austria and Germany. The study focuses on evaluating tasimelteon, a melatonin receptor agonist, as a potential treatment option for helping patients regulate their sleep-wake patterns. The trial uses a comprehensive approach combining subjective reporting through sleep diaries with objective measurements using actigraphy and potentially circadian phase assessments through saliva samples. This research may provide valuable insights into treatment options for individuals whose internal body clocks are misaligned with conventional sleep schedules.