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Evaluating TAK-360 for daytime sleepiness in adults with Idiopathic Hypersomnia

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)

PHASE2 · Takeda · NCT06812078

This study is testing a new medication called TAK-360 to see if it can help adults with Idiopathic Hypersomnia feel less sleepy during the day.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorTakeda (industry)
Locations29 sites (Redwood City, California and 28 other locations)
Trial IDNCT06812078 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and tolerability of TAK-360, a medication that mimics the action of orexin, in adults diagnosed with Idiopathic Hypersomnia (IH). Participants will be randomly assigned to receive either TAK-360 or a placebo to assess its effectiveness in reducing excessive daytime sleepiness. The study aims to determine the appropriate dosage needed for optimal results. By focusing on the unique challenges faced by individuals with IH, the research seeks to provide insights into potential new treatment options.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with Idiopathic Hypersomnia who meet specific weight and BMI criteria.

Not a fit: Patients with excessive daytime sleepiness due to other medical disorders or significant thyroid disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option that helps patients with Idiopathic Hypersomnia stay awake and improve their daily functioning.

How similar studies have performed: Previous studies have shown promise with medications that act like orexin, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Redwood City, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Idiopathic Hypersomnia, TAK-360

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.