Narcolepsy – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Thu, 18 Jun 2026 04:08:06 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Narcolepsy – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Phase 3 Randomized, Double‑Blind, Placebo‑Controlled Study of ALKS 2680 for Excessive Daytime Sleepiness in Adults with Narcolepsy Type 2 https://clinicaltrials.eu/trial/phase-3-randomized-double-blind-placebo-controlled-study-of-alks-2680-for-excessive-daytime-sleepiness-in-adults-with-narcolepsy-type-2/ Sat, 06 Jun 2026 04:04:40 +0000 https://clinicaltrials.eu/trial/phase-3-randomized-double-blind-placebo-controlled-study-of-alks-2680-for-excessive-daytime-sleepiness-in-adults-with-narcolepsy-type-2/ The study focuses on adults who have Narcolepsy Type 2, a condition that causes sudden and uncontrollable episodes of sleep, especially during the day. The medication being tested is a tablet called ALKS 2680, which will be compared with a matching placebo. The purpose of the study is to evaluate the efficacy and safety of this drug for reducing excessive daytime sleepiness in this population.

Participants will take the study tablets once daily for about 12 weeks and will attend regular clinic visits where they will complete questionnaires and undergo simple tests. One questionnaire, the Epworth Sleepiness Scale, asks about the likelihood of falling asleep in everyday situations to measure daytime sleepiness. Another test, the Maintenance of Wakefulness Test, measures how long a person can stay awake while trying to stay alert. Throughout the study, researchers will monitor how the medication affects sleepiness and overall well‑being, while also checking for any side effects.

]]> Phase 3 Randomized Study of ALKS 2680 for Excessive Daytime Sleepiness in Adults with Narcolepsy Type 1 https://clinicaltrials.eu/trial/efficacy-and-safety-of-alks-2680-in-adults-with-narcolepsy-type-1/ Fri, 05 Jun 2026 04:02:57 +0000 https://clinicaltrials.eu/trial/efficacy-and-safety-of-alks-2680-in-adults-with-narcolepsy-type-1/ A clinical investigation is being conducted in adults diagnosed with Narcolepsy Type 1, a rare neurological condition characterized by overwhelming daytime drowsiness and sudden episodes of muscle weakness called cataplexy. The study evaluates the oral tablet form of ALKS 2680 and compares it with an inactive substance known as placebo to determine whether the medication can reduce the persistent feeling of excessive daytime sleepiness, which is the tendency to fall asleep unintentionally during daily activities.

The main aim of the trial is to assess whether the drug improves daytime alertness in participants with this condition. Volunteers will be randomly assigned to receive either the active medication or the inactive comparator, and they will take the assigned tablet each day for approximately twelve weeks. Throughout the study period, participants will attend regular visits where simple questionnaires and brief safety checks will be performed to monitor how they feel and to ensure the treatment is well tolerated.

]]> Study on TAK-861 for Treating Narcolepsy with Cataplexy in Patients https://clinicaltrials.eu/trial/study-on-tak-861-for-treating-narcolepsy-with-cataplexy-in-patients/ Mon, 04 May 2026 07:59:29 +0000 https://clinicaltrials.eu/trial/study-on-tak-861-for-treating-narcolepsy-with-cataplexy-in-patients/ This clinical trial is focused on studying the condition known as narcolepsy with cataplexy, which is also referred to as narcolepsy type 1. Narcolepsy is a sleep disorder that causes excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. The study will evaluate a new treatment called TAK-861, which is taken in the form of a tablet. The purpose of the study is to assess how effective and safe TAK-861 is in treating narcolepsy with cataplexy.

Participants in the study will be randomly assigned to receive either the TAK-861 tablet or a placebo, which looks like the TAK-861 tablet but does not contain the active medication. The study will last for a period of 12 weeks, during which participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The main focus will be on changes in daytime sleepiness, which will be measured using a tool called the Epworth Sleepiness Scale.

In addition to monitoring sleepiness, the study will also look at other aspects of narcolepsy, such as the frequency of cataplexy episodes and overall quality of life. Participants will be asked to complete various assessments and questionnaires to provide a comprehensive understanding of how TAK-861 affects their condition. The study aims to gather valuable information that could lead to improved treatment options for people living with narcolepsy with cataplexy.

]]> 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.

]]> A study testing the safety and how the body processes TAK-861 in children and teenagers aged 6 to 17 years with narcolepsy type 1 https://clinicaltrials.eu/trial/a-study-testing-the-safety-and-how-the-body-processes-tak-861-in-children-and-teenagers-aged-6-to-17-years-with-narcolepsy-type-1/ Wed, 29 Apr 2026 15:07:55 +0000 https://clinicaltrials.eu/trial/a-study-testing-the-safety-and-how-the-body-processes-tak-861-in-children-and-teenagers-aged-6-to-17-years-with-narcolepsy-type-1/ This study is looking at a condition called narcolepsy type 1, which is a sleep disorder where people experience excessive daytime sleepiness and sudden muscle weakness triggered by emotions, a symptom known as cataplexy. The study will use a medication called TAK-861, also known as oveporexton, which comes in tablet form and is taken by mouth. This medication has been designated as an orphan drug, meaning it is being developed to treat a rare condition.

The purpose of this study is to understand how the body of children and teenagers processes this medication by measuring drug levels in the blood over time, and to check if the medication is safe and acceptable for young people to take. The study will include children from 6 years old up to 18 years old who have been diagnosed with narcolepsy type 1. Participants will need to have either a specific genetic marker or very low levels of a brain substance called hypocretin in their spinal fluid, which are both signs of this type of narcolepsy. They will also need to have a body mass index within a certain range and be in generally good health as determined by various medical tests including blood work, physical examination, heart rhythm recording, and vital signs measurements.

During the study, participants will receive a single dose of the medication, and doctors will collect blood samples at different times to see how the drug moves through the body. The study will measure things like the highest amount of drug in the blood, how long it takes to reach that level, and how long the drug stays in the body. Researchers will also watch for any unwanted effects and ask participants and their parents or guardians about how acceptable the medication is to take and what it tastes like. This is an open-label study, which means both the doctors and participants will know that everyone is receiving the active medication rather than a placebo.

]]> A Study to Test the Safety and Effectiveness of TAK-360 in People with Narcolepsy without Cataplexy https://clinicaltrials.eu/trial/a-study-to-test-the-safety-and-effectiveness-of-tak-360-in-people-with-narcolepsy-without-cataplexy/ Wed, 29 Apr 2026 15:07:49 +0000 https://clinicaltrials.eu/trial/a-study-to-test-the-safety-and-effectiveness-of-tak-360-in-people-with-narcolepsy-without-cataplexy/ This study is looking at a condition called Narcolepsy without Cataplexy, also known as NT2. This is a sleep disorder where people experience excessive daytime sleepiness and may suddenly fall asleep during the day, but they do not have sudden muscle weakness or loss of muscle control that can occur in other forms of narcolepsy. The treatment being tested is called TAK-360, which is an experimental medication given as a tablet by mouth. Some participants will receive TAK-360 while others will receive placebo. The purpose of this study is to evaluate the safety and tolerability of TAK-360.

During the study, participants will take TAK-360 or placebo for a period of 4 weeks. The study will look at whether any unwanted effects occur during treatment. The study will also measure changes in daytime sleepiness using a questionnaire called the Epworth Sleepiness Scale, which asks about how likely someone is to fall asleep in different situations. Additionally, a test called the Maintenance of Wakefulness Test will be used, which measures how well someone can stay awake in a quiet, comfortable setting. These measurements will be compared between the group taking TAK-360 and the group taking placebo to see if there are any differences.

Participants in this study will be adults between 18 and 70 years old who have been diagnosed with NT2. The study uses a design where neither the participants nor the doctors know who is receiving the actual medication and who is receiving placebo until the study is completed. This helps ensure that the results are measured fairly and without bias. The study will continue for several weeks and will involve regular visits to check on safety and how well the treatment is working.

]]> 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.

]]> 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 the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy Type 2 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-alks-2680-for-patients-with-narcolepsy-type-2/ Wed, 29 Apr 2026 15:02:58 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-alks-2680-for-patients-with-narcolepsy-type-2/ This clinical trial is focused on studying a condition known as Narcolepsy Type 2, which is a sleep disorder that causes excessive daytime sleepiness. The study will evaluate a treatment called ALKS 2680, which is taken in the form of a tablet. The purpose of the study is to assess the safety and effectiveness of ALKS 2680 in managing symptoms of narcolepsy, particularly excessive daytime sleepiness.

Participants in the study will be randomly assigned to receive either ALKS 2680 or a placebo. The study will have both a double-blind period, where neither the participants nor the researchers know who is receiving the actual medication, and an open-label period, where everyone knows who is receiving the treatment. The study will last for a total of eight weeks, during which the effects of the medication on sleepiness will be closely monitored.

The main goal is to determine how ALKS 2680 affects the ability to stay awake during the day. Participants will undergo various assessments to measure changes in their sleepiness levels and overall health. The study aims to provide valuable information on the potential benefits of ALKS 2680 for individuals with Narcolepsy Type 2.

]]> Study on the Safety and Effectiveness of Pitolisant for Children Aged 6-17 with Narcolepsy, with or without Cataplexy https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-pitolisant-for-children-aged-6-17-with-narcolepsy-with-or-without-cataplexy/ Wed, 29 Apr 2026 15:02:17 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-pitolisant-for-children-aged-6-17-with-narcolepsy-with-or-without-cataplexy/ This clinical trial is focused on studying narcolepsy, a sleep disorder that causes excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. The trial is testing a medication called pitolisant, which is available in film-coated tablets. The purpose of the study is to evaluate the safety and effectiveness of pitolisant in children aged 6 to less than 18 years who have narcolepsy, with or without cataplexy.

Participants in the study will be randomly assigned to receive either pitolisant or a placebo. The study will begin with a double-blind period, where neither the participants nor the researchers know who is receiving the actual medication or the placebo. This will be followed by an open-label period, where all participants will receive pitolisant. The study will last for a total of eight weeks, during which the effects of the medication on symptoms like excessive daytime sleepiness and the frequency of cataplexy episodes will be monitored.

The trial aims to observe any improvements in the symptoms of narcolepsy and to ensure the medication is well-tolerated by the participants. The study will also monitor any side effects and changes in health indicators such as heart rate and blood tests. This research is important for understanding how pitolisant can help manage narcolepsy in children and improve their quality of life.

]]> Study on TAK-861 for Treating Narcolepsy with Cataplexy in Patients https://clinicaltrials.eu/trial/study-on-tak-861-for-treating-narcolepsy-with-cataplexy-in-patients-2/ Wed, 29 Apr 2026 14:58:41 +0000 https://clinicaltrials.eu/trial/study-on-tak-861-for-treating-narcolepsy-with-cataplexy-in-patients-2/ This clinical trial is focused on studying the condition known as Narcolepsy with Cataplexy, also referred to as Narcolepsy Type 1. Narcolepsy is a sleep disorder that causes excessive daytime sleepiness and sudden muscle weakness called cataplexy. The study will evaluate a new treatment called TAK-861, which is taken in tablet form. The purpose of the study is to assess how well TAK-861 can improve excessive daytime sleepiness in people with Narcolepsy Type 1.

Participants in the study will be randomly assigned to receive either the TAK-861 tablet or a placebo, which looks like the TAK-861 tablet but does not contain the active medication. The study will last for a period of 12 weeks, during which participants will take the assigned tablets and attend regular check-ups to monitor their condition and any changes in their symptoms.

The main goal is to see if TAK-861 can reduce sleepiness as measured by a tool called the Epworth Sleepiness Scale, which helps to assess how likely someone is to fall asleep in different situations. The study will also look at other aspects of narcolepsy, such as the frequency of cataplexy episodes and overall quality of life. Participants’ health and safety will be closely monitored throughout the study to ensure their well-being.

]]> Study on the Long-term Safety of TAK-861 for Patients with Narcolepsy Type 1 https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-tak-861-for-patients-with-narcolepsy-type-1/ Wed, 29 Apr 2026 14:30:39 +0000 https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-tak-861-for-patients-with-narcolepsy-type-1/ This clinical trial is focused on studying a condition known as Narcolepsy with Cataplexy, which is also referred to as Narcolepsy Type 1. Narcolepsy is a sleep disorder that causes excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. The study is evaluating a treatment called TAK-861, which is taken in tablet form. The purpose of the study is to assess the long-term safety and tolerability of this medication in individuals with this condition.

Participants in the study will take TAK-861 over a period of time to see how well they tolerate the medication and to monitor any side effects that may occur. The study aims to ensure that the medication is safe for long-term use. Participants will be monitored for any treatment-emergent adverse events, which are any unwanted effects that occur after starting the medication.

The study will also look at changes in sleep patterns and symptoms from the beginning of the study to the end. This includes measuring how long participants can stay awake during the day and tracking any changes in their cataplexy symptoms using a diary. The study is expected to continue until early 2028, providing valuable information on the long-term use of TAK-861 for managing Narcolepsy with Cataplexy.

]]> Study on Blood Pressure Changes in Narcolepsy Patients Switching from High-Sodium Oxybate to JZP258 (Oxybate Mixed-Salt Formulation) https://clinicaltrials.eu/trial/study-on-blood-pressure-changes-in-narcolepsy-patients-switching-from-high-sodium-oxybate-to-jzp258-oxybate-mixed-salt-formulation/ Wed, 29 Apr 2026 14:26:08 +0000 https://clinicaltrials.eu/trial/study-on-blood-pressure-changes-in-narcolepsy-patients-switching-from-high-sodium-oxybate-to-jzp258-oxybate-mixed-salt-formulation/ This clinical trial is focused on studying the effects of switching medications in people with narcolepsy, a sleep disorder that causes excessive daytime sleepiness and sudden sleep attacks. The study involves changing from a high-sodium version of a medication called oxybate to a new formulation known as XYWAV. XYWAV is an oral solution that contains a mix of different salts, including sodium, calcium, magnesium, and potassium oxybate. The purpose of the study is to evaluate how this switch affects blood pressure in participants.

Participants in the study will first be assessed to establish their baseline blood pressure. They will then switch from their current high-sodium oxybate medication to XYWAV. Throughout the study, participants will have their blood pressure monitored regularly to observe any changes. The study aims to understand how the new medication formulation impacts blood pressure over a 24-hour period, including during the day and night.

The study is designed to last for several months, during which participants will continue to take the new medication as directed. The results will help determine if XYWAV is a suitable alternative for managing narcolepsy while potentially offering benefits related to blood pressure management. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being throughout the study.

]]> Study on the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy Type 1 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-alks-2680-for-patients-with-narcolepsy-type-1/ Wed, 29 Apr 2026 14:22:25 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-alks-2680-for-patients-with-narcolepsy-type-1/ This clinical trial is focused on studying narcolepsy type 1, a sleep disorder that causes excessive daytime sleepiness and sudden muscle weakness known as cataplexy. The study will evaluate the safety and effectiveness of a new treatment called ALKS 2680, which is taken as a tablet. Participants in the study will receive either ALKS 2680 or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to assess how well ALKS 2680 works in reducing excessive daytime sleepiness in people with narcolepsy type 1. The study will be conducted over a period of several weeks. During this time, participants will be randomly assigned to different groups to receive varying doses of ALKS 2680 or a placebo. The study will include both a double-blind period, where neither the participants nor the researchers know who is receiving the treatment or placebo, and an open-label period, where all participants will receive ALKS 2680.

Throughout the study, participants will be monitored for changes in their symptoms and any side effects. The study aims to find the most effective dose of ALKS 2680 while ensuring it is safe for use. Participants will have regular check-ups and assessments to track their progress and the impact of the treatment on their narcolepsy symptoms.

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