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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)

A Study of TAK-360 in Adults with Idiopathic Hypersomnia

Nonomura Hidenori

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

smb.Japanclinicalstudydisclosure@takeda.com

Contact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

+81-6-6204-2111

smb.Japanclinicalstudydisclosure@takeda.com

Recruiting

Feb. 07, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.
8. The participant has any prior exposure to an oral Takeda orexin receptor 2 (OX2R) agonist within the past 3 months.

Both

Idiopathic Hypersomnia

TAK-360
Participants will receive TAK-360 tablets, orally, for 4 weeks.

Placebo
Participants will receive TAK-360 matching placebo tablets, orally, for 4 weeks.

1. Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 8
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.

1. Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
Time Frame: Baseline, Week 4
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.

2. Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score
Time Frame: Baseline, Week 4
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.

+81-3-6665-0572

Dec. 27, 2024

Yes

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.

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