A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Key facts
- Where
- Berlin, Regensburg, and Schwerin, GermanySee the 3 sites
- Phase
- Phase 2/3
Could this be for you?
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?
Source: NCT05816382, who can take part
Where in Germany
- Advanced Sleep Research GmbHBerlin, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
- Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbHSchwerin, GermanyTaking people
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 doctorTrial details
- Who runs it
- Takeda
- Trial code
- NCT05816382EU 2023-508462-15-00
- Record updated
- 5 March 2026
- Original description
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.Read full original descriptionShow less
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
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.
Inclusion: 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.
Exclusion: 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.