Early access
Sign in
Taking people in SwitzerlandPhase 2/3

Long-term safety of TAK-861 in people with narcolepsy type 1

Checks long-term safety of TAK-861 in people with narcolepsy type 1.

Key facts

Who runs it
Takeda
Where
Barmelweid, Bern, and Lugano, SwitzerlandSee the 3 sitesAlso in 14 other countries, 59 sites
Trial code
Registry title
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with narcolepsy type 1 (NT1) who have finished an earlier controlled trial of TAK-861. It tests the long-term safety of TAK-861.

Age
16 Years to 70 Years
Sex
All sexes
Disease stage
Narcolepsy type 1 (narcolepsy with cataplexy, sudden muscle weakness).
Earlier treatment
Must have completed a controlled trial with TAK-861. People who stopped the earlier trial because of side effects cannot join.
Biomarker or test result
ALT and AST liver tests must not be > 1.5 times the upper limit of normal (ULN).

Main reasons for not taking part

  • A side effect from the earlier trial drug that is still severe
  • Risk of suicide, or major depression now or in the past 6 months
  • Epilepsy or a history of seizures
  • History of stroke, brain bleeding, heart attack, heart failure or serious heart disease
  • Cancer in the past 5 years

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 Switzerland

Also in 14 other countries, 59 sites

  • Klinik Barmelweid AGBarmelweid, SwitzerlandTaking people
  • Universitaetsspital Bern, InselspitalBern, SwitzerlandTaking people
  • Neurocenter of Southern SwitzerlandLugano, SwitzerlandTaking people

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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
Plain-language title
Long-term safety of TAK-861 in people with narcolepsy type 1Generated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT05816382, who can take part
Record updated
5 March 2026