TAK-861 for Narcolepsy
Trial Summary
What is the purpose of this trial?
This trial is testing TAK-861, a new drug, on people with type 1 and type 2 narcolepsy. The goal is to see if it can help reduce excessive daytime sleepiness and sudden muscle weakness. The study will involve up to 160 participants from previous studies and will last about two years.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude participants who need to take certain medications for conditions like anxiety, depression, heart disease, or significant liver, lung, or kidney disease.
How is the drug TAK-861 different from other narcolepsy treatments?
TAK-861 is unique because it is an orexin 2 receptor agonist, which means it specifically targets and activates receptors in the brain that help regulate wakefulness, potentially offering a more targeted approach to treating narcolepsy compared to other treatments that may have broader effects or more side effects.12345
Research Team
Study Director
Principal Investigator
Takeda
Eligibility Criteria
This trial is for people with narcolepsy who have already taken TAK-861 in earlier studies without serious side effects. They shouldn't have other sleep disorders, major depression recently, digestive issues affecting drug absorption, seizures, significant heart or liver diseases, recent strokes or cancer within the last 5 years.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAK-861 for up to approximately 5 years to evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TAK-861 (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier