Recruiting

TAK-360 for Idiopathic Hypersomnia Safety and Efficacy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

TAK-360

+ Placebo

DrugOther
Who is being recruted

Mental Disorders+4

+ Disorders of Excessive Somnolence

+ Nervous System Diseases

From 18 to 70 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorTakeda
Study ContactTakeda Contact
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)
NCT06812078
Principal SponsorTakeda
Study ContactTakeda Contact
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Mental DisordersDisorders of Excessive SomnolenceNervous System DiseasesSleep Wake DisordersIdiopathic HypersomniaSleep Disorders, IntrinsicDyssomnias

Criteria

7 exclusion criteria prevent from participating
The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].

The participant has medically significant thyroid disease.

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.)

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).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive TAK-360 tablets, orally, for 4 weeks.

Group II

Placebo
Participants will receive TAK-360 matching placebo tablets, orally, for 4 weeks.

Study 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

Recruiting

Takeda Site 11

Redwood City, United StatesOpen Takeda Site 11 in Google Maps
Recruiting

Takeda Site 10

Santa Ana, United States
Recruiting

Takeda Site 27

Colorado Springs, United States
Recruiting

Takeda Site 19

Brandon, United States
Recruiting
29 Study Centers