Clinical trial NCT06812078: A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Hypersomnia
Keywords: Idiopathic Hypersomnia
TAK-360
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 8
Secondary outcomes:
measure: Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
timeFrame: Baseline, Week 4
measure: Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Takeda Site 11
state: California
city: Santa Ana
country: United States
facility: Takeda Site 10
state: California
city: Colorado Springs
country: United States
facility: Takeda Site 27
state: Colorado
city: Brandon
country: United States
facility: Takeda Site 19
state: Florida
city: Winter Park
country: United States
facility: Takeda Site 14
state: Florida
city: Saint Louis
country: United States
facility: Takeda Site 29
state: Missouri
city: Denver
country: United States
facility: Takeda Site 16
state: North Carolina
city: Huntersville
country: United States
facility: Takeda Site 15
state: North Carolina
city: Cincinnati
country: United States
facility: Takeda Site 12
state: Ohio
city: Cincinnati
country: United States
facility: Takeda Site 17
state: Ohio
city: Columbia
country: United States
facility: Takeda Site 13
state: South Carolina
city: San Antonio
country: United States
facility: Takeda Site 18
state: Texas
city: Norfolk
country: United States
facility: Takeda Site 28
state: Virginia
city: Montpellier
country: France
facility: Takeda Site 1
state: Hrault
city: Nantes
country: France
facility: Takeda Site 3
state: Pays De Loire
city: Paris
country: France
facility: Takeda Site 2
city: Sha Tin
country: Hong Kong
facility: Takeda Site 4
city: Pozzilli
country: Italy
facility: Takeda Site 6
state: Isernia
city: Rome
country: Italy
facility: Takeda Site 7
state: Roma
city: Verona
country: Italy
facility: Takeda Site 26
state: Veneto
city: Bologna
country: Italy
facility: Takeda Site 5
city: Fukuoka-Shi Hakata-Ku
country: Japan
facility: Takeda Site 25
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Takeda Site 23
state: Fukuoka
city: Kohoku-ku, Yokohama-Shi
country: Japan
facility: Takeda Site 22
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Takeda Site 20
state: Kumamoto
city: Yodogawa-ku, Osaka-shi
country: Japan
facility: Takeda Site 21
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Takeda Site 24
state: Tokyo
city: Vitoria
country: Spain
facility: Takeda Site 9
state: Alava
city: Madrid
country: Spain
facility: Takeda Site 8
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: