A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy) (NCT07633301)
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
🩺 Plain-English Summary (8th-Grade Level)
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends. The participants will have to visit the clinic multiple times during this study.
Who can join: Review the eligibility criteria below.
Location: Takeda Site 12 — 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 (18 Sites)
- Takeda Site 12 — Redwood City, California
- Takeda Site 14 — Miami, Florida
- Takeda Site 13 — Cincinnati, Ohio
- Takeda Site 2 — Macquarie Park, New South Wales
- Takeda Site 4 — Beijing, Beijing Municipality
- Takeda Site 3 — Guangzhou, Guangdong
- Takeda Site 5 — Zhengzhou, Henan
- Takeda Site 6 — Herault, Montpelier
- Takeda Site 7 — Paris,
- Takeda Site 8 — Bologna, Emilia-Romagna
- Takeda Site 9 — Verona, Veneto
- Takeda Site 17 — Fukuoka, Fukuoka
- Takeda Site 1 — Kumamoto, Kumamoto
- Takeda Site 18 — Isahaya-shi, Nagasaki
- Takeda Site 15 — Yodogawa-ku, Osaka-shi, Osaka
- Takeda Site 16 — Shinjuku-ku, Tokyo
- Takeda Site 11 — Barcelona,
- Takeda Site 10 — Madrid,
📞 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 Narcolepsy Type 1
- A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia — Cullman, Alabama
- A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 — Cullman, Alabama
- A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia — Auburn, Alabama
- A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia — Auburn, Alabama
- A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) — Miami, Florida
- A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence — Colorado Springs, Colorado
Explore by condition: All Narcolepsy Type 1 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.