Long-term test of TAK-360 in people with narcolepsy or idiopathic hypersomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a long-term extension study of TAK-360 in adults with centrally mediated sleep disorders. It aims to evaluate long-term tolerability and safety of TAK-360 compared with placebo in NT1, NT2, and IH after prior treatment exposure. The trial follows participants who completed a parent TAK-360 trial, continuing the same intervention and placebo arms as applicable. Primary goals focus on safety and tolerability during extended use, with secondary observations of duration of wakefulness and daytime functioning in a controlled setting. Sites are located in California and Colorado, led by Takeda, with no additional collaborators reported.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participant is willing and able to understand and fully comply with trial procedures and requirements.
2. Participant has a confirmed diagnosis of either NT1, NT2, or 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.

Key Exclusion Criteria:

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.

Where it's running

• Takeda Site 23
  Chula Vista, California, United States Recruiting
• Takeda Site 25
  Santa Ana, California, United States Recruiting
• Takeda Site 14
  Colorado Springs, Colorado, United States Recruiting
• Takeda Site 11
  Brandon, Florida, United States Recruiting
• Takeda Site 30
  Miami, Florida, United States Recruiting
• Takeda Site 7
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.