TAK-861-2003
Recruiting
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Clinicaltrials.gov
#NCT05816382EU CTIS
#2023-508462-15-00EudraCT
#2022-002965-13EudraCT
#2023-508462-15jRCT
#jRCT2031230135About this clinical trial
The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
US
ES
JP
9+
Interventional Phase 2/Phase 3 clinical trial.
At a glance
What medical conditions are being studied?
Narcolepsy Type 1
What is the clinical trial testing?
TAK-861
How many participants are being enrolled?
500
Are placebos part of the clinical trial?
No
When is the clinical trial being conducted?
Apr 2023 - Feb 2028
How long is participation in the clinical trial?
Up to approximately 5 years.
Key requirements
Sexes
All
Age
16 to 70 Years
Healthy volunteers?
No
Entry criteria
Both men and women can take part.
Must be at least 16 years to 70 years old.
Must have a diagnosis of narcolepsy type 1 or 2 who has completed a controlled study with TAK-861.
Additional entry criteria will be discussed with the study doctor.
