TAK-360 for Idiopathic Hypersomnia Safety and Efficacy
TAK-360
+ Placebo
Mental Disorders+4
+ Disorders of Excessive Somnolence
+ Nervous System Diseases
Treatment Study
Summary
Study start date: February 7, 2025
Actual date on which the first participant was enrolled.Idiopathic Hypersomnia (IH) is a condition that causes people to feel extremely sleepy during the day, even if they sleep for long hours at night. This can make waking up in the morning very difficult and cause problems with concentration and daily activities. The study is testing a drug called TAK-360, which works like a brain chemical called orexin that helps keep people awake and alert. The goal is to see if TAK-360 is safe for adults with IH, how well they can tolerate it, and if it can effectively help them stay awake. This research is important because it may lead to better treatments for those struggling with excessive daytime sleepiness. In the study, participants are randomly chosen to receive either the drug TAK-360 or a placebo, which is a substance that looks like the drug but contains no active medicine. This helps determine the actual effects of TAK-360. The study aims to measure how well TAK-360 works compared to the placebo, looking at improvements in wakefulness and any side effects. Participants will be closely monitored to evaluate both the safety and effectiveness of TAK-360 in managing symptoms of IH.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 29 locations
Takeda Site 10
Santa Ana, United StatesTakeda Site 27
Colorado Springs, United StatesTakeda Site 19
Brandon, United States