A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Phase 2

Recruiting

Brief Summary: Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. 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 NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.

Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that 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.

Recruitment & Eligibility

Inclusion Criteria

The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].
The participant has a documented, current diagnosis of NT2.

Key

Exclusion Criteria

The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
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 (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
The participant has a clinically significant history of head injury or head trauma.
The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	Up to 15 Weeks	An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score	Baseline, Week 4	The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)	Baseline, Week 4	The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.

Locations (30): Takeda Site 14
🇺🇸
Redwood City, California, United States
Takeda Site 10
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Santa Ana, California, United States
Takeda Site 1
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Colorado Springs, Colorado, United States
Takeda Site 13
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Brandon, Florida, United States
Takeda Site 3
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Orlando, Florida, United States
Takeda Site 4
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Saint Louis, Missouri, United States
Takeda Site 8
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Denver, North Carolina, United States
Takeda Site 6
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Huntersville, North Carolina, United States
Takeda Site 5
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Cincinnati, Ohio, United States
Takeda Site 2
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Columbia, South Carolina, United States
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Takeda Site 14
🇺🇸Redwood City, California, United States