Unknown Brain & Nervous System NIHR-supported project Digestion, Kidneys & Other Organs

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust Cambridge Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Ongoing

In plain English

AI plain-English summary

A drug that switches on the brain’s natural wakefulness chemical, orexin, is being tested in 500 adults with narcolepsy type 1 to see if it is safe and tolerable over several years. Narcolepsy with cataplexy leaves people unable to stay awake during the day and causes sudden muscle collapse triggered by emotions. Existing treatments manage symptoms but do not replace the orexin that these patients lack. This study, an extension of an earlier trial, tracks whether TAK-861 can safely reduce excessive daytime sleepiness and cataplexy attacks over up to five years of daily use. If the drug proves safe and effective, it could become the first treatment that directly targets the underlying orexin deficiency in narcolepsy. That would shift care from symptom management toward a more fundamental correction of the sleep-wake disruption, potentially allowing people with the condition to work, drive, and live without constant fear of sudden sleep or collapse. The study also gathers long-term safety data needed for regulatory approval, which is a prerequisite for any new prescription medicine.

View original technical description
This is an extension study for participants who participated in a prior study of TAK-861 (called the parent study). Participants may have at most a 3-month break between the parent study and the Screening Period for this study or may directly start this study whenthey finish the parent study.The study medication,TAK-861,is an investigational drug which means it is not approved by any regulatory authority to be prescribed by doctors. It is being developed as a possible treatment for sleep disorders, such as narcolepsy with cataplexy. TAK-861 works by turning on a receptor for orexin, a chemical people normally have that helps regulate wakefulness and sleep in the brain.The purpose of this study is to gather the following information about the study medication:• How safe and tolerable the study medication is for participants• How the study medication affects excessive daytime sleepiness and cataplexyEveryone in the study will receive TAK-861 but different doses will be given. The study doctor, study staff, and participants will not know which dose of TAK-861 you are receiving. Participants will be assigned to receive the same treatment as in the parent study, unless they were previously on placebo, or if their dose is not available in this study. Participants who were on placebo or a currently unavailable dose in the parent study will be randomised by computer (like flipping a coin) to one of the dose groups available for their specific condition.This study will be split into the following periods: Screening, Treatment and Follow-up. The study will include approximately 500 adults with NT1 between the ages of 18 and 70 and will last up to approximately 5years but your participation could be shorter depending on when you enter the study relative to when the study is planned to end. TAK-861 treatment is given by mouth (orally) every day.Participants will be asked about their medical history, any medications and will undergo some tests and examinations.

Researchers

Clare Bolton (Principal Investigator)

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