A Study of TAK-360 in Adults With Idiopathic Hypersomnia

A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Hypersomnia
• Intervention / Treatment: Drug: TAK-360; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Takeda Site 2
  • Hrault
    • Montpellier, Hrault, France
      • Recruiting
      • Takeda Site 1
  • Pays de Loire
    • Nantes, Pays de Loire, France, 44093
      • Recruiting
      • Takeda Site 3
• Hong Kong
  • Shatin, Hong Kong
    • Withdrawn
    • Takeda Site 4
• Italy
  • Bologna, Italy, 40139
    • Recruiting
    • Takeda Site 5
  • Isernia
    • Pozzilli, Isernia, Italy
      • Recruiting
      • Takeda Site 6
  • Roma
    • Rome, Roma, Italy, 00133
      • Recruiting
      • Takeda Site 7
  • Veneto
    • Verona, Veneto, Italy
      • Recruiting
      • Takeda Site 26
• Japan
  • Fukuoka
    • Fukuoka-Shi Hakata-Ku, Fukuoka, Japan, 812-0025
      • Recruiting
      • Takeda Site 25
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Recruiting
      • Takeda Site 23
  • Kanagawa
    • Kohoku-ku, Yokohama-Shi, Kanagawa, Japan, 222-0033
      • Recruiting
      • Takeda Site 22
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 862-0954
      • Recruiting
      • Takeda Site 20
  • Osaka
    • Yodogawa-ku, Osaka-shi, Osaka, Japan, 532-0003
      • Recruiting
      • Takeda Site 21
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 112-0012
      • Recruiting
      • Takeda Site 24
• Spain
  • Madrid, Spain, 28043
    • Recruiting
    • Takeda Site 8
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 1004
      • Recruiting
      • Takeda Site 9
• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Takeda Site 11
    • Santa Ana, California, United States, 92705
      • Recruiting
      • Takeda Site 10
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Recruiting
      • Takeda Site 27
  • Florida
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Takeda Site 19
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Takeda Site 14
  • Missouri
    • St Louis, Missouri, United States, 63123
      • Recruiting
      • Takeda Site 29
  • North Carolina
    • Denver, North Carolina, United States, 28037
      • Recruiting
      • Takeda Site 16
    • Huntersville, North Carolina, United States, 28078-5082
      • Recruiting
      • Takeda Site 15
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Recruiting
      • Takeda Site 12
    • Cincinnati, Ohio, United States, 45245
      • Recruiting
      • Takeda Site 17
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Recruiting
      • Takeda Site 13
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Takeda Site 18
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Takeda Site 28

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 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.

Key Exclusion Criteria:

1. 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 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 Events (TEAEs)	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 Week 8

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 Idiopathic Hypersomnia Severity Scale (IHSS) Total Score	IHSS is a 14-item self-assessment questionnaire, to measure the severity, frequency and functional impact of the three key IH symptoms (during a recall period of "past 7 days"). The IHSS includes 14 items in total; two items (1 and 2) on nighttime sleep duration and quality, three items (3, 4 and 5) on sleep inertia and sleep drunkenness after nighttime sleep and one (8) after daytime nap, and three items (6, 7 and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10 to 14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and eight items on a 4-point Likert scale; the Likert scale is a point scale which is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0 to 50), and higher scores indicate more severe symptoms.	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): February 7, 2025
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2026

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Idiopathic Hypersomnia; TAK-360
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Idiopathic Hypersomnia; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: TAK-360-2002; 2024-517712-29-00 (Ctis); jRCT2031240669 (Registry Identifier: jRCT)

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