A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Public ClinicalTrials.gov record NCT06812078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that. Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
Study identification
- NCT ID
- NCT06812078
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 96 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2025
- Primary completion
- Nov 29, 2026
- Completion
- Nov 29, 2026
- Last update posted
- Jul 14, 2026
2025 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Takeda Site 11 | Redwood City | California | 94063 | Recruiting |
| Takeda Site 10 | Santa Ana | California | 92705 | Recruiting |
| Takeda Site 27 | Colorado Springs | Colorado | 80918 | Recruiting |
| Takeda Site 19 | Brandon | Florida | 33511 | Recruiting |
| Takeda Site 14 | Winter Park | Florida | 32789 | Recruiting |
| Takeda Site 29 | St Louis | Missouri | 63123 | Recruiting |
| Takeda Site 16 | Denver | North Carolina | 28037 | Recruiting |
| Takeda Site 15 | Huntersville | North Carolina | 28078-5082 | Recruiting |
| Takeda Site 12 | Cincinnati | Ohio | 45245 | Recruiting |
| Takeda Site 17 | Cincinnati | Ohio | 45245 | Recruiting |
| Takeda Site 13 | Columbia | South Carolina | 29201 | Recruiting |
| Takeda Site 18 | San Antonio | Texas | 78229 | Recruiting |
| Takeda Site 28 | Norfolk | Virginia | 23507 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06812078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06812078 live on ClinicalTrials.gov.