A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Purpose
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.
Condition
- Idiopathic Hypersomnia
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Redwood City 5386834, California 5332921 94063
Santa Ana 5392900, California 5332921 92705
Colorado Springs 5417598, Colorado 5417618 80918
Brandon 4148757, Florida 4155751 33511
Winter Park 4178560, Florida 4155751 32789
St Louis 4407066, Missouri 4398678 63123
Huntersville 4472370, North Carolina 4482348 28078-5082
Cincinnati 4508722, Ohio 5165418 45245
Cincinnati 4508722, Ohio 5165418 45245
Columbia 4575352, South Carolina 4597040 29201
San Antonio 4726206, Texas 4736286 78229
Norfolk 4776222, Virginia 6254928 23507
More Details
- NCT ID
- NCT06812078
- Status
- Recruiting
- Sponsor
- Takeda