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)
3 other identifiers
interventional
96
6 countries
29
Brief Summary
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.
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 Feb 2025
Shorter than P25 for phase_2
29 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
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 6, 2025
CompletedStudy Start
First participant enrolled
February 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 16, 2026
March 24, 2026
March 1, 2026
1.4 years
February 3, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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 Idiopathic Hypersomnia Severity Scale (IHSS) Total Score
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 or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
- The participant has a documented, current diagnosis of IH.
You may not qualify if:
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \[other than IH\].
- 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 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 (less than \[\<\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (29)
Takeda Site 11
Redwood City, California, 94063, United States
Takeda Site 10
Santa Ana, California, 92705, United States
Takeda Site 27
Colorado Springs, Colorado, 80918, United States
Takeda Site 19
Brandon, Florida, 33511, United States
Takeda Site 14
Winter Park, Florida, 32789, United States
Takeda Site 29
St Louis, Missouri, 63123, United States
Takeda Site 16
Denver, North Carolina, 28037, United States
Takeda Site 15
Huntersville, North Carolina, 28078-5082, United States
Takeda Site 12
Cincinnati, Ohio, 45245, United States
Takeda Site 17
Cincinnati, Ohio, 45245, United States
Takeda Site 13
Columbia, South Carolina, 29201, United States
Takeda Site 18
San Antonio, Texas, 78229, United States
Takeda Site 28
Norfolk, Virginia, 23507, United States
Takeda Site 1
Montpellier, Hrault, France
Takeda Site 3
Nantes, Pays de Loire, 44093, France
Takeda Site 2
Paris, 75013, France
Takeda Site 4
Shatin, Hong Kong
Takeda Site 6
Pozzilli, Isernia, Italy
Takeda Site 7
Rome, Roma, 00133, Italy
Takeda Site 26
Verona, Veneto, Italy
Takeda Site 5
Bologna, 40139, Italy
Takeda Site 25
Fukuoka-Shi Hakata-Ku, Fukuoka, 812-0025, Japan
Takeda Site 23
Kurume-shi, Fukuoka, 830-0011, Japan
Takeda Site 22
Kohoku-ku, Yokohama-Shi, Kanagawa, 222-0033, Japan
Takeda Site 20
Kumamoto, Kumamoto, 862-0954, Japan
Takeda Site 21
Yodogawa-ku, Osaka-shi, Osaka, 532-0003, Japan
Takeda Site 24
Bunkyo-ku, Tokyo, 112-0012, Japan
Takeda Site 9
Vitoria-Gasteiz, Alava, 1004, Spain
Takeda Site 8
Madrid, 28043, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
February 3, 2025
First Posted
February 6, 2025
Study Start
February 7, 2025
Primary Completion (Estimated)
July 16, 2026
Study Completion (Estimated)
July 16, 2026
Last Updated
March 24, 2026
Record last verified: 2026-03
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.