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A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions

A Study of TAK-360 in People With Narcolepsy or 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

June. 11, 2026

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

1. Participant is willing and able to understand and fully comply with trial procedures and requirements.
2. Participant has a confirmed diagnosis of either narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH), and has completed the treatment period of a parent TAK-360 trial.
3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.

1. Participant has a positive pregnancy test or is lactating/breastfeeding.
2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
5. Participant has developed a new history of seizures.
6. Participant has experienced clinically significant head injury, per investigator opinion.
7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [<] 5 years ago), or cerebral haemorrhage.
8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.
10. Participant has developed a history of cancer in the past 5 years.

Both

Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2

TAK-360 Long Term Extension (LTE) Phase:
Participants will receive TAK-360 for up to approximately 5 years in this trial.

1. Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to approximately 5 years

1. All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Time Frame: Baseline through Year 5

2. All Participants: Change from Baseline in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
Time Frame: Baseline through Month 6

3. IH Participants: Change From Baseline in IH Severity Scale (IHSS) Total Score
Time Frame: Baseline through Year 5

4. NT1 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT)
Time Frame: Baseline through Year 5

5. NT2 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-2-CT)
Time Frame: Baseline, through Year 5

6. NT1 Participants: Change from Baseline in Weekly Cataplexy Rate (WCR) Using the Participant-Reported Cataplexy eDiary
Time Frame: Baseline, through Month 24

+81-3-6665-0572

Mar. 27, 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.

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