Taking peoplePhase 2/3
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Key facts
- Who runs it
- Takeda
- Where
- Helsinki and Tampere, FinlandSee the 2 sitesAlso in 14 other countries, 60 sites
- Trial code
- NCT05816382
- EU 2023-508462-15-00
- EudraCT 2022-002965-13
- JRCT2031230135
- U1111-1283-1888
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 500 people, planned
- Started
- 5 Apr 2023
- Expected to end
- 28 Feb 2028
- Type of study
- Interventional
- Treatments tested
- TAK-861
- Record updated
- 5 March 2026
Who can take part
- Age
- 16 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment
Who cannot take part
- Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS)
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs
- Participant has epilepsy or history of seizure
- Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications
- Participant has a history of cerebral ischemia, transient ischemic attack (less than (<) 5 years ago), or cerebral hemorrhage
- Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure
- Participant has a history of cancer in the past 5 years
- The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN)
- Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 70 years old?
Where in Finland
Also in 14 other countries, 60 sites
- Suomen Terveystalo OyHelsinki, FinlandNo longer taking part
- Tampere University HospitalTampere, FinlandNo longer taking part
About the trial
What the trial wants to find out
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
The group in the trial
- TAK-861Treatment being tested
In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
- Fit questions
- Built from NCT05816382, who can take part
- Record updated
- 5 March 2026