A Study of TAK-861 in Participants With Narcolepsy Type 1

Summary

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

Timeline

Start

2023-01-09

Primary completion

2023-12-14

Completion

2023-12-14

Publications

• Lammers GJ, Plazzi G, Mignot E, Pizza F, Dauvilliers Y, Barateau L, Maruff P, Scammell TE, Latzman RD, Naylor M, Olsson T, Stukalin E, Tanaka S, Volfson D, Khachadourian V, Harel BT. Effects of Oveporexton, an Orexin Receptor 2-Selective Agonist, on Cognition in Narcolepsy Type 1: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2026 Feb 1;83(2):145-152. doi: 10.1001/jamaneurol.2025.4825.
• Dauvilliers Y, Plazzi G, Mignot E, Lammers GJ, Del Rio Villegas R, Khatami R, Taniguchi M, Abraham A, Hang Y, Kadali H, Lamberton M, Sheikh S, Stukalin E, Neuwirth R, Swick TJ, Tanaka S, von Hehn C, von Rosenstiel P, Wang H, Cai A, Naylor M, Olsson T. Oveporexton, an Oral Orexin Receptor 2-Selective Agonist, in Narcolepsy Type 1. N Engl J Med. 2025 May 15;392(19):1905-1916. doi: 10.1056/NEJMoa2405847.

Drugs

Indications