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)

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.

Study Overview

• Status: Recruiting
• Conditions: Narcolepsy Type 2
• Intervention / Treatment: Drug: TAK-360; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Takeda Site 28
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510515
      • Recruiting
      • Takeda Site 29
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • Takeda Site 51
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Takeda Site 27
• France
  • Paris, France, 75013
    • Recruiting
    • Takeda Site 15
  • Hérault
    • Montpellier, Hérault, France, 34090
      • Withdrawn
      • Takeda Site 17
• Italy
  • Bologna, Italy, 40139
    • Recruiting
    • Takeda Site 23
  • Lazio
    • Rome, Lazio, Italy, 133
      • Recruiting
      • Takeda Site 22
  • Veneto
    • Verona, Veneto, Italy, 37134
      • Recruiting
      • Takeda Site 31
• Japan
  • Fukuoka, Japan, 812-0025
    • Recruiting
    • Takeda Site 52
  • Kanagawa
    • Kohoku-ku, Yokohama-Shi, Kanagawa, Japan, 222-0033
      • Recruiting
      • Takeda Site 24
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 862-0954
      • Recruiting
      • Takeda Site 9
  • Nagasaki
    • Isahaya-shi, Nagasaki, Japan, 854-0081
      • Not yet recruiting
      • Takeda Site 53
  • Okinawa
    • Urasoe-Shi, Okinawa, Japan, 901-2132
      • Recruiting
      • Takeda Site 30
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 162-0851
      • Recruiting
      • Takeda Site 20
    • Sumida-Ku, Tokyo, Japan, 130-0004
      • Recruiting
      • Takeda Site 26
  • Ôsaka
    • Yodogawa-ku, Osaka-shi, Ôsaka, Japan, 532-0003
      • Recruiting
      • Takeda Site 12
• South Korea
  • Daegu Gwang'yeogsi
    • Junggu, Daegu Gwang'yeogsi, South Korea
      • Recruiting
      • Takeda Site 16
  • Gyeonggido
    • Suwon, Gyeonggido, South Korea, 16247
      • Recruiting
      • Takeda Site 19
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 3080
      • Recruiting
      • Takeda Site 21
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Takeda Site 18
• United States
  • Alabama
    • Auburn, Alabama, United States, 36832
      • Recruiting
      • Takeda Site 36
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Takeda Site 39
  • California
    • Chula Vista, California, United States, 91910
      • Recruiting
      • Takeda Site 40
    • Redwood City, California, United States, 94063-3132
      • Recruiting
      • Takeda Site 14
    • Santa Ana, California, United States, 92705-8519
      • Recruiting
      • Takeda Site 10
  • Colorado
    • Colorado Springs, Colorado, United States, 80918-3408
      • Recruiting
      • Takeda Site 1
  • Florida
    • Bradenton, Florida, United States, 34209
      • Not yet recruiting
      • Takeda Site 48
    • Brandon, Florida, United States, 33511-5719
      • Recruiting
      • Takeda Site 13
    • Jacksonville, Florida, United States, 32209
      • Not yet recruiting
      • Takeda Site 46
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • Takeda Site 44
    • Miami, Florida, United States, 33176
      • Recruiting
      • Takeda Site 35
    • Orlando, Florida, United States, 32803-1468
      • Recruiting
      • Takeda Site 3
    • Orlando, Florida, United States, 32807
      • Recruiting
      • Takeda Site 33
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Takeda Site 32
  • Maryland
    • Bowie, Maryland, United States, 20715
      • Not yet recruiting
      • Takeda Site 49
  • Michigan
    • Lansing, Michigan, United States, 48911
      • Not yet recruiting
      • Takeda Site 50
    • Lathrup Village, Michigan, United States, 48076
      • Recruiting
      • Takeda Site 34
  • Missouri
    • St Louis, Missouri, United States, 63123-6968
      • Recruiting
      • Takeda Site 4
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Takeda Site 37
  • North Carolina
    • Denver, North Carolina, United States, 28037
      • Recruiting
      • Takeda Site 8
    • Huntersville, North Carolina, United States, 28078-5082
      • Recruiting
      • Takeda Site 6
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Takeda Site 41
  • Ohio
    • Cincinnati, Ohio, United States, 45245-4500
      • Recruiting
      • Takeda Site 5
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Takeda Site 45
  • South Carolina
    • Columbia, South Carolina, United States, 29201-2923
      • Recruiting
      • Takeda Site 2
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Takeda Site 38
    • Dallas, Texas, United States, 75235
      • Not yet recruiting
      • Takeda Site 43
    • El Paso, Texas, United States, 79912
      • Not yet recruiting
      • Takeda Site 42
    • Mansfield, Texas, United States, 76063
      • Not yet recruiting
      • Takeda Site 47
    • San Antonio, Texas, United States, 78229-4849
      • Recruiting
      • Takeda Site 7
  • Virginia
    • Norfolk, Virginia, United States, 23510-1021
      • Recruiting
      • Takeda Site 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. 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.

Key Exclusion Criteria:

1. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAK-360; Participants will receive TAK-360 tablets, orally, for 4 weeks.	Drug: TAK-360; TAK-360 tablet.
Placebo Comparator: Placebo; Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.	Other: Placebo; TAK-360 matching placebo tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score	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.	Baseline, Week 4
Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)	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.	Baseline, Week 4

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Narcolepsy without Cataplexy; NT2; TAK-360
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Narcolepsy; Cataplexy; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: TAK-360-2001; 2024-517711-70-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No