Recruiting

Phase 2

TAK-360A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Sponsor:

Takeda

Code:

NCT06812078

Conditions

Idiopathic Hypersomnia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

TAK-360

Placebo

Study Details

Brief summary:

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.

The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that.

Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Conditions

Idiopathic Hypersomnia

Study ID

NCT06812078

Start date

Feb 7, 2025

Status verified date

Jul, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAK-360

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

placebo comparator: Placebo

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

Interventions

TAK-360

TAK-360 tablet.

Placebo

TAK-360 matching placebo tablet.

Primary outcome measure

Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 8 ]

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327 medinfoUS@takeda.com

Locations

Takeda Site 11

Recruiting

Redwood City, California, United States, 94063

Takeda Site 10

Recruiting

Santa Ana, California, United States, 92705

Takeda Site 27

Recruiting

Colorado Springs, Colorado, United States, 80918

Takeda Site 19

Recruiting

Brandon, Florida, United States, 33511

Takeda Site 14

Recruiting

Winter Park, Florida, United States, 32789

Takeda Site 29

Recruiting

St Louis, Missouri, United States, 63123

Takeda Site 16

Recruiting

Denver, North Carolina, United States, 28037

Takeda Site 15

Recruiting

Huntersville, North Carolina, United States, 28078-5082

Takeda Site 12

Recruiting

Cincinnati, Ohio, United States, 45245

Takeda Site 17

Recruiting

Cincinnati, Ohio, United States, 45245

Takeda Site 13

Recruiting

Columbia, South Carolina, United States, 29201

Takeda Site 18

Recruiting

San Antonio, Texas, United States, 78229

Takeda Site 28

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

Takeda

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

Idiopathic Hypersomnia
TAK-360

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Takeda on 2026-07-15.