A Study of TAK-360 in Adults With Idiopathic Hypersomnia (NCT06812078)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Takeda Site 11 — Redwood City, California
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- Takeda Site 11 — Redwood City, California
- Takeda Site 10 — Santa Ana, California
- Takeda Site 27 — Colorado Springs, Colorado
- Takeda Site 19 — Brandon, Florida
- Takeda Site 14 — Winter Park, Florida
- Takeda Site 29 — St Louis, Missouri
- Takeda Site 16 — Denver, North Carolina
- Takeda Site 15 — Huntersville, North Carolina
- Takeda Site 12 — Cincinnati, Ohio
- Takeda Site 17 — Cincinnati, Ohio
- Takeda Site 13 — Columbia, South Carolina
- Takeda Site 18 — San Antonio, Texas
- Takeda Site 28 — Norfolk, Virginia
- Takeda Site 1 — Montpellier, Hrault
- Takeda Site 3 — Nantes, Pays de Loire
- Takeda Site 2 — Paris,
- Takeda Site 4 — Shatin,
- Takeda Site 6 — Pozzilli, Isernia
- Takeda Site 7 — Rome, Roma
- Takeda Site 26 — Verona, Veneto
- Takeda Site 5 — Bologna,
- Takeda Site 25 — Fukuoka-Shi Hakata-Ku, Fukuoka
- Takeda Site 23 — Kurume-shi, Fukuoka
- Takeda Site 22 — Kohoku-ku, Yokohama-Shi, Kanagawa
- Takeda Site 20 — Kumamoto, Kumamoto
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Idiopathic Hypersomnia
- A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia — Cullman, Alabama
- A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia — Brandon, Florida
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) — Birmingham, Alabama
- Low Sodium Oxybate in Patients With Idiopathic Hypersomnia — Phoenix, Arizona
Explore by condition: All Idiopathic Hypersomnia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.