Hypersomnia – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:22:20 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Hypersomnia – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Long-term Safety Study of ORX750 for Patients with Narcolepsy and Idiopathic Hypersomnia Who Completed a Previous ORX750 Trial https://clinicaltrials.eu/trial/long-term-safety-study-of-orx750-for-patients-with-narcolepsy-and-idiopathic-hypersomnia-who-completed-a-previous-orx750-trial/ Thu, 30 Apr 2026 13:08:37 +0000 https://clinicaltrials.eu/trial/long-term-safety-study-of-orx750-for-patients-with-narcolepsy-and-idiopathic-hypersomnia-who-completed-a-previous-orx750-trial/ This study involves people with narcolepsy and idiopathic hypersomnia, which are conditions that cause excessive daytime sleepiness and difficulties staying awake during the day. Narcolepsy is a sleep disorder where a person experiences sudden sleep attacks and may have trouble controlling when they fall asleep, while idiopathic hypersomnia is a condition where a person feels extremely sleepy during the day despite getting enough sleep at night. The treatment being tested is ORX750, which is given as a capsule taken by mouth. The purpose of this study is to evaluate the long-term safety and tolerability of ORX750 in people who have already completed a previous clinical trial with this medication.

Participants in this study will be those who finished the full treatment period in an earlier study with ORX750. They will continue taking the medication for an extended period to help researchers understand how safe it is when used over a longer time. During the study, participants will attend regular visits where various health checks will be performed. These checks include blood tests to examine blood cells and body chemistry, measurements of blood pressure and heart rate, weight monitoring, and heart function tests using an electrocardiogram. Researchers will also use questionnaires to assess any thoughts about self-harm and will monitor for any unwanted effects that may occur during treatment.

The study will also measure how well ORX750 works by looking at changes in sleepiness levels. This will be done using a test called the maintenance of wakefulness test, which measures how long a person can stay awake in a quiet, comfortable setting, and a questionnaire that asks about sleepiness during daily activities. Blood samples will be collected at different times to measure the amount of ORX750 in the body. The maximum treatment period for participants will be 63 days, during which they will need to stop taking any other medications used to treat their sleep condition.

]]> Study of ALKS 2680 to treat excessive daytime sleepiness in people with idiopathic hypersomnia https://clinicaltrials.eu/trial/study-of-alks-2680-to-treat-excessive-daytime-sleepiness-in-people-with-idiopathic-hypersomnia/ Wed, 29 Apr 2026 15:06:49 +0000 https://clinicaltrials.eu/trial/study-of-alks-2680-to-treat-excessive-daytime-sleepiness-in-people-with-idiopathic-hypersomnia/ This clinical trial focuses on Idiopathic Hypersomnia, a sleep disorder characterized by excessive daytime sleepiness without a known cause. The study will test a new medication called ALKS 2680, which is taken as oral tablets, compared to a placebo. The main goal is to evaluate how well ALKS 2680 works in treating excessive daytime sleepiness in people with Idiopathic Hypersomnia.

The study will last 8 weeks and will test different doses of ALKS 2680. During the study, participants will receive either ALKS 2680 tablets or matching placebo tablets. The medication doses being tested range from 10 to 18 milligrams per day. The study is designed as a double-blind trial, which means neither the participants nor the doctors conducting the study will know who receives which treatment.

The effectiveness of the treatment will be measured by tracking changes in sleepiness levels using standardized assessment tools. Throughout the study, participants’ health and safety will be closely monitored through various medical checks. The study will also look at how well participants tolerate the medication and any effects it may have on their daily functioning.

]]> Study on the Safety and Effects of ORX750 for Patients with Narcolepsy and Idiopathic Hypersomnia https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-orx750-for-patients-with-narcolepsy-and-idiopathic-hypersomnia/ Wed, 29 Apr 2026 15:04:56 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-orx750-for-patients-with-narcolepsy-and-idiopathic-hypersomnia/ This clinical trial is focused on studying two sleep disorders: narcolepsy and idiopathic hypersomnia. Narcolepsy is a condition that causes excessive daytime sleepiness and sudden sleep attacks, while idiopathic hypersomnia is characterized by excessive sleepiness without a known cause. The treatment being tested in this study is a medication called ORX750, which is taken in capsule form.

The purpose of the study is to evaluate the safety and tolerability of ORX750. Participants will be randomly assigned to receive either ORX750 or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of 28 days, during which participants will take the medication orally. Throughout the study, various assessments will be conducted to monitor the participants’ health and any side effects they may experience.

Participants will undergo regular check-ups, including laboratory tests and heart monitoring, to ensure their safety. The study will also measure how the medication affects sleep patterns and daytime sleepiness. This research aims to provide valuable information about the potential benefits and risks of ORX750 for individuals with narcolepsy and idiopathic hypersomnia.

]]> Study of TAK-360 tablets to evaluate safety and effectiveness in people with Idiopathic Hypersomnia https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-tak-360-for-patients-with-idiopathic-hypersomnia/ Wed, 29 Apr 2026 15:04:50 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-tak-360-for-patients-with-idiopathic-hypersomnia/ This study focuses on Idiopathic Hypersomnia (IH), a sleep disorder characterized by excessive daytime sleepiness despite getting normal or long amounts of nighttime sleep. The research evaluates a new medication called TAK-360, which is being tested as a potential treatment for this condition. The medication comes in tablet form and is taken by mouth.

The purpose of this research is to determine if TAK-360 is safe and well-tolerated by people with Idiopathic Hypersomnia. The study will compare TAK-360 tablets with placebo to understand how effective the medication is in treating the symptoms of Idiopathic Hypersomnia. The treatment period will last for 4 weeks.

During the study, participants will be randomly assigned to receive either TAK-360 or placebo. Neither the participants nor the doctors will know which treatment is being given. The study will monitor how participants respond to the treatment by measuring changes in their daytime sleepiness and other symptoms related to Idiopathic Hypersomnia. The researchers will also track any side effects that may occur during the treatment period.

]]> Long-Term Study on the Safety and Effects of ALKS 2680 for Patients with Narcolepsy Type 1 and Type 2 https://clinicaltrials.eu/trial/long-term-study-on-the-safety-and-effects-of-alks-2680-for-patients-with-narcolepsy-type-1-and-type-2/ Wed, 29 Apr 2026 15:04:45 +0000 https://clinicaltrials.eu/trial/long-term-study-on-the-safety-and-effects-of-alks-2680-for-patients-with-narcolepsy-type-1-and-type-2/ This clinical trial is focused on studying the effects of a medication called ALKS 2680 in individuals with narcolepsy, a sleep disorder that causes excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. The study includes participants with both Narcolepsy Type 1 and Type 2. The purpose of the study is to evaluate the safety and how well people tolerate ALKS 2680 over a long period.

Participants in the study will take ALKS 2680 in the form of a tablet, which is taken by mouth. The study will monitor participants for any side effects and changes in their health. This includes regular checks of vital signs, such as heart rate and blood pressure, and assessments of sleepiness and cataplexy symptoms. The study will also use tests like the Epworth Sleepiness Scale to measure changes in sleepiness and the Maintenance of Wakefulness Test to see how long participants can stay awake during the day.

The study is designed to last for several years, allowing researchers to gather information on the long-term effects of ALKS 2680. Participants will be closely monitored throughout the study to ensure their safety and to collect data on how the medication affects their narcolepsy symptoms over time. This research aims to provide valuable insights into the potential benefits and risks of using ALKS 2680 as a treatment for narcolepsy.

]]> Study on Melatonin and Light Therapy for Adults with Idiopathic Hypersomnia https://clinicaltrials.eu/trial/study-on-melatonin-and-light-therapy-for-adults-with-idiopathic-hypersomnia/ Wed, 29 Apr 2026 14:25:41 +0000 https://clinicaltrials.eu/trial/study-on-melatonin-and-light-therapy-for-adults-with-idiopathic-hypersomnia/ This clinical trial is focused on studying Idiopathic Hypersomnia, a condition characterized by excessive daytime sleepiness despite having a good night’s sleep. The treatment being tested involves a combination of evening doses of melatonin and morning light therapy. Melatonin is a natural hormone that helps regulate sleep-wake cycles, and in this study, it is given in a fast-release form as a capsule. The study also includes a comparison with a placebo, which is a substance with no active therapeutic effect.

The purpose of the study is to evaluate the effectiveness of this treatment in reducing symptoms of idiopathic hypersomnia. Participants will be randomly assigned to receive either the active treatment or the placebo for a period of six weeks. During this time, they will take a 2 mg dose of melatonin in the evening and undergo bright light therapy in the morning, or they will receive the placebo equivalents. The study aims to measure changes in symptoms using a specific scale designed for idiopathic hypersomnia.

Participants will be monitored throughout the study to assess any changes in their condition. The trial is designed to provide valuable information on whether this combination of melatonin and light therapy can help manage symptoms of idiopathic hypersomnia effectively. The study will last for a total of 45 days, with regular check-ins to track progress and ensure the safety and well-being of all participants.

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