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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)

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

June. 04, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/ m^2) (inclusive).
2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.

1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
3. The participant has a clinically significant history of head injury or head trauma.
4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
5. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
6. The participant has a history of cancer in the past 5 years
7. The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
8. The participant plans to participate in any other interventional trial while participating in TAK-360-2004.
9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.

Both

Narcolepsy Type 1

TAK-360:
Participants will receive TAK-360 tablets, orally.

Placebo:
Participants will receive TAK-360 matching placebo tablets, orally.

1. Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 28 weeks

1. Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
Time Frame: Baseline, Week 6

2. Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
Time Frame: Baseline, Week 6

3. Weekly Cataplexy Rate (WCR) at Week 6
Time Frame: Week 6

+81-3-6665-0572

April. 10, 2026

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.

France/Italy/Spain/United States/China/Australia