A Phase 3 Study of TAK-861 in patients with Narcolepsy
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)
IRAS ID
1010083
Contact name
Melissa Naylor
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Eudract number
2023-508465-32
Clinicaltrials.gov Identifier
Research summary
Narcolepsy is a sleep disorder that disrupts the sleep-wake cycle and causes extreme sleepiness during the day. People with narcolepsy type 1 (NT1) also have sudden, unexpected muscle weakness (cataplexy) and may have hallucinations, sleep paralysis and disturbed nighttime sleep.
Orexin is a chemical in the brain that controls many body functions including the sleep-wake cycle. People with NT1 have low levels of orexin in the fluid surrounding the brain. TAK-861 stimulates brain cells that orexin would normally stimulate and therefore may reduce key symptoms of NT1. This study’s purpose is to confirm the results of a previous study which showed that people with NT1 had an improvement in their EDS and cataplexy symptoms when treated with TAK-861.
The primary objective of this study is to learn how effective TAK-861 is in improving EDS after 12 weeks of treatment. This will be measured by the Maintenance of Wakefulness Test, a test done during the day to find out how long a participant can stay awake while laying back in a dimly lit room with no other activity going on.
This is a double-blinded study which means that neither the participants nor the study doctors will know which treatment each participant is taking (TAK-861, in different doses, or placebo).
Participants will first be checked to make sure they meet the rules for taking part in the study. Participants must be 18 to 70 years, be diagnosed with NT1, and meet other study criteria. Participants who meet the study rules will then receive either TAK-861 or placebo for 12 weeks. At the end of the study, participants will either decide to continue in an extension study, in which all participants will receive TAK-861 or will be followed-up for 4 weeks after their last dose.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0152
Date of REC Opinion
28 Aug 2024
REC opinion
Further Information Favourable Opinion