A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Launched by TAKEDA · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TAK-360, which is being tested for adults with a condition known as Idiopathic Hypersomnia (IH). People with IH often feel extremely sleepy during the day, even after getting a lot of sleep at night. This can make it hard for them to focus or carry out their daily activities. TAK-360 is designed to help keep people awake by acting like a natural brain chemical called orexin, which helps regulate alertness. The main goals of the study are to see how safe TAK-360 is and how well it works for helping people with IH stay awake.

To participate in this study, individuals must be between the ages of 18 and 65, weigh at least 40 kilograms, and have a confirmed diagnosis of Idiopathic Hypersomnia. Participants will be randomly assigned to receive either TAK-360 or a placebo (a pill that looks like the medication but doesn’t contain any active ingredients). This helps researchers understand the true effects of TAK-360. Participants can expect to have regular check-ins with the research team to monitor their health and how they respond to the treatment. If you're considering joining, it's important to know that certain medical conditions or histories may prevent eligibility, such as other sleep disorders or significant medical issues.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
• • 2. The participant has a documented, current diagnosis of IH.
• Key Exclusion Criteria:
• • 1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \[other than IH\].
• • 2. The participant has medically significant thyroid disease.
• • 3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
• • 4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
• • 5. The participant has a clinically significant history of head injury or head trauma.
• • 6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
• • 7. The participant has a history of cerebral ischemia, transient ischemic attack (less than \[\<\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.