Ongoing Clinical Trials for Hypersomnia
This article provides information about 3 ongoing clinical trials for hypersomnia, specifically focusing on idiopathic hypersomnia, a sleep disorder characterized by excessive daytime sleepiness despite getting adequate nighttime sleep. These trials are testing different treatments including new investigational drugs (TAK-360 and ORX750) and a combination therapy approach using melatonin with bright light therapy. Trials are currently being conducted in France, Italy, and Spain.
Clinical trial locations
- France
- Italy
- Spain
Study of TAK-360 tablets to evaluate safety and effectiveness in people with Idiopathic Hypersomnia
This trial is evaluating TAK-360, a new investigational medication being tested for the treatment of idiopathic hypersomnia. The study is being conducted in Italy, Spain, and France, with a planned duration from June 2025 to April 2026.
Who can participate: This study is open to adults between 18 and 70 years old who have been diagnosed with idiopathic hypersomnia within the past 5 years. Participants must weigh at least 40 kilograms and have a Body Mass Index between 16 and 38. Both men and women can join, provided they do not belong to vulnerable population groups.
Who cannot participate: The study excludes people younger than 18 or older than 65 years, pregnant or breastfeeding women, and those with a history of severe allergic reactions to medications. People diagnosed with other sleep disorders besides idiopathic hypersomnia, those with serious medical conditions affecting the heart, liver, or kidneys, and individuals with a history of substance abuse within the past year cannot participate. Other exclusion factors include mental health conditions that could affect results, irregular sleep patterns due to shift work, uncontrolled high blood pressure, history of seizures or epilepsy, and recent major surgery within the past three months.
What the study involves: Participants will be randomly assigned to receive either TAK-360 tablets or a placebo for a treatment period of 4 weeks. Neither the participants nor the study doctors will know which treatment is being given. The study will monitor how participants respond to treatment by measuring changes in daytime sleepiness using two scales: the Epworth Sleepiness Scale and the Idiopathic Hypersomnia Severity Scale. Researchers will also carefully track any side effects that may occur during the treatment period.
Investigational drug: TAK-360 is a new medication in development specifically for idiopathic hypersomnia. The primary goal of this study is to determine whether it is safe and well-tolerated by patients, while also evaluating its effectiveness in reducing symptoms of excessive daytime sleepiness. Researchers are working to identify the right dose that provides the best balance between effectiveness and safety.
Study on Melatonin and Light Therapy for Adults with Idiopathic Hypersomnia
This trial is testing a combination treatment approach using evening melatonin and morning bright light therapy for adults with idiopathic hypersomnia. The study is being conducted exclusively in France and will last for a total of 45 days, with a 6-week treatment phase.
Who can participate: The study is open to both men and women between 18 and 40 years old who have been diagnosed with idiopathic hypersomnia at a specialized center. To qualify, symptoms must have lasted more than 3 months with a total sleep time of at least 11 hours, confirmed by a sleep study done within the last 12 months. Participants must have stable medication for the month before joining and during the 10-week study period. Women must use effective contraception during the month before joining and throughout the study. Participants must be able to follow the treatment schedule and be affiliated with social security insurance.
Who cannot participate: People who are not diagnosed with idiopathic hypersomnia, those under 18 years old, and individuals who are part of vulnerable populations such as those unable to give consent or in dependent relationships with study staff cannot participate.
What the study involves: After initial eligibility assessments and informed consent, participants will be randomly assigned to receive either the active treatment or placebo for 6 weeks. The active treatment group will take 2mg of fast-release melatonin orally each evening and undergo bright light therapy each morning. The placebo group will receive inactive versions of both treatments. Throughout the study, symptoms will be monitored using the Idiopathic Hypersomnia Severity Scale, with the primary goal being to measure changes in symptoms before and after the treatment period.
Investigational treatments: This trial uses two complementary approaches. Melatonin is a natural hormone that helps regulate sleep-wake cycles. In this study, a 2mg fast-release tablet is taken in the evening to help manage sleep patterns. Bright light therapy involves exposure to bright light in the morning to help adjust the body’s internal clock, improving alertness and energy levels during the day. The combination of these two treatments is being tested to see if it can effectively reduce symptoms by improving the overall sleep-wake cycle.
Study on the Safety and Effects of ORX750 for Patients with Narcolepsy and Idiopathic Hypersomnia
This trial is evaluating ORX750, a new investigational medication for treating both narcolepsy and idiopathic hypersomnia. The study is being conducted in Spain, Italy, and France, with an expected completion date in November 2025.
Who can participate: The study is open to adults between 18 and 65 years old with a Body Mass Index between 17 and 37 kg/m². Participants must have a confirmed diagnosis of Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia according to specific medical guidelines. Importantly, participants must be willing and able to stop taking all current medications used for treating these conditions during the study period.
Who cannot participate: People with sleep disorders other than narcolepsy and idiopathic hypersomnia cannot participate. The study also excludes those outside the specified age range, individuals from vulnerable populations who cannot give informed consent, and people with medical conditions that might interfere with the study or patient safety. Other exclusions include current participation in another clinical trial, history of substance abuse or dependency, pregnancy or breastfeeding, recent major surgery or planned surgery during the study period, and known allergies to the study medication or its ingredients.
What the study involves: The study follows a double-blind, placebo-controlled design lasting 28 days. After initial assessments confirming eligibility, participants will be randomly assigned to receive either ORX750 capsules or placebo once daily by mouth. Neither participants nor the study team will know which treatment is being given. Throughout the study, regular follow-up visits will include physical exams, laboratory tests, heart monitoring, and assessments of sleep patterns and daytime sleepiness. The study team will carefully monitor for any side effects or adverse reactions.
Investigational drug: ORX750 is being studied for its potential to help manage symptoms in people with narcolepsy and idiopathic hypersomnia. The medication is taken orally in capsule form. The primary focus of this trial is to assess the safety and tolerability of ORX750, while also investigating how the body processes the medication and how it affects symptoms of excessive daytime sleepiness. ORX750 is believed to work by affecting certain brain chemicals that regulate sleep and wakefulness, though the exact mechanism is still under investigation.
Summary
Currently, there are 3 ongoing clinical trials focused on idiopathic hypersomnia in Europe. These trials are geographically concentrated in three countries: France, Italy, and Spain, with France hosting all three trials while Italy and Spain each host two. This geographic distribution provides good access for patients in Western and Southern Europe.
The trials represent different therapeutic approaches to managing this condition. Two trials are testing completely new investigational medications—TAK-360 and ORX750—both focused primarily on evaluating safety and tolerability while also measuring effectiveness in reducing symptoms. A third trial takes a different approach by testing a combination of melatonin and bright light therapy, representing a more natural intervention strategy that works with the body’s circadian rhythms.
The inclusion criteria vary somewhat across studies, particularly regarding age ranges. The melatonin and light therapy study targets a younger population aged 18-40, while the medication trials include broader age ranges up to 65 or 70 years old. All studies require confirmed diagnoses and various health criteria to ensure participant safety.
These trials reflect the ongoing search for effective treatments for idiopathic hypersomnia, a condition that significantly impacts quality of life. Patients interested in participating should discuss these options with their sleep specialists to determine eligibility and suitability for any of these studies.
