TAK-861-2001
Completed
A Study of TAK-861 in Participants With Narcolepsy Type 1
About this clinical trial
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.
At a glance
What medical conditions were being studied?
Narcolepsy Type 1
What was the clinical trial testing?
Placebo, TAK-861
How many participants were enrolled?
112
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?
Participants will be in the study for up to 23 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 body mass index within the range 18 to 40 kg/m^2.
Additional entry criteria will be discussed with the study doctor.
