A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
2 other identifiers
interventional
88
7 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2025
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
May 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 20, 2026
February 12, 2026
February 1, 2026
1.3 years
April 23, 2025
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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.
Up to 15 Weeks
Secondary Outcomes (2)
Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
Baseline, Week 4
Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
Baseline, Week 4
Study Arms (2)
TAK-360
EXPERIMENTALParticipants will receive TAK-360 tablets, orally, for 4 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (30)
Takeda Site 14
Redwood City, California, 94063-3132, United States
Takeda Site 10
Santa Ana, California, 92705-8519, United States
Takeda Site 1
Colorado Springs, Colorado, 80918-3408, United States
Takeda Site 13
Brandon, Florida, 33511-5719, United States
Takeda Site 3
Orlando, Florida, 32803-1468, United States
Takeda Site 4
St Louis, Missouri, 63123-6968, United States
Takeda Site 8
Denver, North Carolina, 28037, United States
Takeda Site 6
Huntersville, North Carolina, 28078-5082, United States
Takeda Site 5
Cincinnati, Ohio, 45245-4500, United States
Takeda Site 2
Columbia, South Carolina, 29201-2923, United States
Takeda Site 7
San Antonio, Texas, 78229-4849, United States
Takeda Site 11
Norfolk, Virginia, 23510-1021, United States
Takeda Site 28
Beijing, Beijing Municipality, 100053, China
Takeda Site 29
Guangzhou, Guangzhou, 510515, China
Takeda Site 27
Shanghai, Shanghai Municipality, 200040, China
Takeda Site 17
Montpellier, Hérault, 34090, France
Takeda Site 15
Paris, 75013, France
Takeda Site 22
Rome, Lazio, 133, Italy
Takeda Site 31
Verona, Veneto, 37134, Italy
Takeda Site 23
Bologna, 40139, Italy
Takeda Site 24
Kohoku-ku, Yokohama-Shi, Kanagawa, 222-0033, Japan
Takeda Site 9
Kumamoto, Kumamoto, 862-0954, Japan
Takeda Site 30
Urasoe-Shi, Okinawa, 901-2132, Japan
Takeda Site 20
Shinjuku-ku, Tokyo, 162-0851, Japan
Takeda Site 26
Sumida-Ku, Tokyo, 130-0004, Japan
Takeda Site 12
Yodogawa-ku, Osaka-shi, Ôsaka, 532-0003, Japan
Takeda Site 16
Junggu, Daegu Gwang'yeogsi, South Korea
Takeda Site 19
Suwon, Gyeonggido, 16247, South Korea
Takeda Site 21
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Takeda Site 18
Madrid, 28046, Spain
Related Links
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2025
First Posted
May 1, 2025
Study Start
May 6, 2025
Primary Completion (Estimated)
August 20, 2026
Study Completion (Estimated)
August 20, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.