TAK-861-2002
Completed
A Study of TAK-861 in Participants With Narcolepsy Type 2
About this clinical trial
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
At a glance
What medical conditions were being studied?
Narcolepsy Type 2
What was the clinical trial testing?
Placebo, TAK-861 2 mg, TAK-861 2 mg and 5 mg
How many participants were enrolled?
71
Were placebos part of the clinical trial?
Yes
When was the clinical trial conducted?
Jan 2023 - Dec 2023
How long was participation in the clinical trial?
Up to approximately 18 weeks
Key requirements
Sexes
All
Age
16 to 70 Years
Healthy volunteers?
No
Entry criteria
Both men and women can take part.
Must be from 18 to 70. In Japan from 16 to 70 years, inclusive, may be included.- Must have a diagnosis of Narcolepsy Type 2.
Must have body mass index within the range 18 to 40 kg/m2.
Additional entry criteria will be discussed with the study doctor.
