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Evaluating TAK-861 for treating narcolepsy type 1

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Phase2; Phase3 Interventional Takeda · NCT05816382

This study is testing a new medication called TAK-861 to see if it can help people with narcolepsy type 1 feel less sleepy during the day and reduce their sudden muscle weakness.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment500 (estimated)
Ages16 Years to 70 Years
SexAll
SponsorTakeda Industry-sponsored
Locations52 sites (Birmingham, Alabama and 51 other locations)
Trial IDNCT05816382 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of TAK-861 in participants diagnosed with narcolepsy type 1 who have previously participated in controlled studies with the drug. The trial will monitor improvements in narcolepsy symptoms, particularly excessive daytime sleepiness and cataplexy episodes. Up to 500 patients will be enrolled, and they will receive either of two doses of TAK-861 based on their prior treatment. The study is a long-term extension that will last approximately five years and is conducted across multiple centers worldwide.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with narcolepsy type 1 who have completed a prior controlled study involving TAK-861.

Not a fit: Patients with severe treatment-emergent adverse events from previous studies or those with other significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from narcolepsy type 1 by reducing daytime sleepiness and cataplexy episodes.

How similar studies have performed: Other studies involving TAK-861 have shown promise, but this specific long-term extension is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1\. 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 criteria:

1. 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.
2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (\>) 1.5 times the upper limit of normal (ULN).
4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
7. Participant has epilepsy or history of seizure.
8. 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.
9. Participant has a history of cerebral ischemia, transient ischemic attack (less than (\<) 5 years ago), or cerebral hemorrhage.
10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
11. Participant has a history of cancer in the past 5 years.

Where this trial is running

Birmingham, Alabama and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Narcolepsy Type 1Drug Therapy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.