A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Purpose
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.
Condition
- Narcolepsy Type 2
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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]. 2. The participant has a documented, current diagnosis of NT2.
Exclusion Criteria
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2. 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 (HCV) 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 (<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
Auburn, Alabama 36832
Chandler, Arizona 85224
Chula Vista, California 91910
Redwood City, California 94063-3132
Santa Ana, California 92705-8519
Colorado Springs, Colorado 80918-3408
Bradenton, Florida 34209
Brandon, Florida 33511-5719
Miami, Florida 33155
Miami, Florida 33176
Orlando, Florida 32803-1468
Orlando, Florida 32807
Atlanta, Georgia 30328
Bowie, Maryland 20715
Lansing, Michigan 48911
Lathrup Village, Michigan 48076
St Louis, Missouri 63123-6968
Middletown, New Jersey 07748
Denver, North Carolina 28037
Huntersville, North Carolina 28078-5082
Winston-Salem, North Carolina 27103
Cincinnati, Ohio 45245-4500
Cleveland, Ohio 44106
Columbia, South Carolina 29201-2923
Austin, Texas 78731
El Paso, Texas 79912
San Antonio, Texas 78229-4849
Norfolk, Virginia 23510-1021
More Details
- Status
- Recruiting
- Sponsor
- Takeda