A Study of TAK-861 for Narcolepsy with Cataplexy
This study is testing a drug called TAK-861 to see how well it treats narcolepsy type 1 (NT1), a sleep disorder that causes extreme daytime sleepiness and sudden muscle weakness (cataplexy). The main goal is to find out if TAK-861 is effective and if its effects last over time. You might be able to join if you are 16 to 70 years old, have NT1, and your body mass index (BMI) is between 18 and 40. All participants will first take TAK-861 for several months. If you meet certain conditions, you will then be randomly assigned to continue taking TAK-861 or switch to a placebo (an inactive pill) for up to 4 weeks. The study will measure how long it takes for your sleepiness to return during this period. About 88 people will participate in this study, which is currently recruiting.
- Study design
- This is an interventional study where all participants first take TAK-861. Then, some participants will be randomly assigned to either continue TAK-861 or take a placebo for up to 4 weeks.
- What's involved
- You will take TAK-861 tablets for several months, followed by up to 4 weeks of either TAK-861 or placebo tablets.
- Compensation
- Not stated in the trial record.
- Follow-up
- If your symptoms worsen during the randomized withdrawal period, you will stop treatment and may be invited to a separate long-term study. If you don't join the extension study, you will be followed for 4 weeks after your last dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
At a glance
Conditions
Where it's being run
25 sites across 19 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Time to Loss of Response in the Epworth Sleepiness Scale (ESS) Score During the Up to 4-Week RW PeriodUp to 4-week RW period
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within normal range.