Evaluating TAK-360 for daytime sleepiness in adults with 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Takeda Site 11
  Redwood City, California, United States Recruiting
• Takeda Site 10
  Santa Ana, California, United States Recruiting
• Takeda Site 27
  Colorado Springs, Colorado, United States Recruiting
• Takeda Site 19
  Brandon, Florida, United States Recruiting
• Takeda Site 14
  Winter Park, Florida, United States Recruiting
• Takeda Site 29
  St Louis, Missouri, United States Recruiting

Study contacts

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

Similar studies

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

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

  This study tests TAK-360 over an extended period to see if it is tolerable for people with narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia who completed an earlier TAK-360 trial.

  Recruiting at 33 sites Phase 2/3 Takeda · Chula Vista, California and 32 other locations · NCT07646678

• Expanded-dosing Xywav vs placebo in narcolepsy and IH

  This study tests whether expanded nightly dosing of Xywav helps adults with narcolepsy or idiopathic hypersomnia, compared with placebo.

  Recruiting at 15 sites Phase 3 Jazz Pharmaceuticals · Birmingham, Alabama and 14 other locations · NCT07625280

• Phase 3 HBS-301 for idiopathic hypersomnia

  This trial will test whether the oral medicine HBS-301 helps adults with idiopathic hypersomnia reduce daytime sleepiness, sleep inertia, and fatigue.

  Recruiting at 42 sites Phase 3 Harmony Biosciences Management, Inc. · Birmingham, Alabama and 41 other locations · NCT07500090

• Long-term ORX750 treatment for people with narcolepsy or idiopathic hypersomnia

  This open-label extension will try continued ORX750 treatment in people with narcolepsy or idiopathic hypersomnia who completed the earlier ORX750 parent study.

  Recruiting at 24 sites Phase 2 Centessa Pharmaceuticals (UK) Limited · Auburn, Alabama and 23 other locations · NCT07096674

• Diet changes to reduce sleepiness in narcolepsy and idiopathic hypersomnia

  This project will try whether a 12-week whole-food ketogenic diet versus an isocaloric standard whole-food diet reduces daytime sleepiness and improves quality of life in adults with narcolepsy or idiopathic hypersomnia.

  Recruiting University of Sydney · Macquarie Park, New South Wales · NCT07006233

• Long-term treatment with ALKS 2680 for narcolepsy and idiopathic hypersomnia

  This study is testing how well a new medication called ALKS 2680 works for people with narcolepsy or idiopathic hypersomnia over a long period of time.

  Recruiting at 50 sites Phase 2/3 Alkermes, Inc. · Cullman, Alabama and 49 other locations · NCT06767683

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.