A Study to Evaluate the Long-term Safety and Tolerability of TAK-861
Research type
Research Study
Full title
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
IRAS ID
1010811
Contact name
Alice Cai
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Eudract number
2023-508462-15
Clinicaltrials.gov Identifier
Research summary
This is an extension study for participants who participated in a prior study of TAK-861 (called the parent study). Participants may have at most a 3-month break between the parent study and the Screening Period for this study or may directly start this study when
they finish the parent study.
The study medication,TAK-861,is an investigational drug which means it is not approved by any regulatory authority to be prescribed by doctors. It is being developed as a possible treatment for sleep disorders, such as narcolepsy with cataplexy. TAK-861 works by turning on a receptor for orexin, a chemical people normally have that helps regulate wakefulness and sleep in the brain.
The purpose of this study is to gather the following information about the study medication:
• How safe and tolerable the study medication is for participants
• How the study medication affects excessive daytime sleepiness and cataplexy
Everyone in the study will receive TAK-861 but different doses will be given. The study doctor, study staff, and participants will not know which dose of TAK-861 you are receiving. Participants will be assigned to receive the same treatment as in the parent study, unless they were previously on placebo, or if their dose is not available in this study. Participants who were on placebo or a currently unavailable dose in the parent study will be randomised by computer (like flipping a coin) to one of the dose groups available for their specific condition.
This study will be split into the following periods: Screening, Treatment and Follow-up. The study will include approximately 500 adults with NT1 between the ages of 18 and 70 and will last up to approximately 5years but your participation could be shorter depending on when you enter the study relative to when the study is planned to end. TAK-861 treatment is given by mouth (orally) every day.
Participants will be asked about their medical history, any medications and will undergo some tests and examinations.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0230
Date of REC Opinion
10 Dec 2024
REC opinion
Further Information Favourable Opinion