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TAK-861 for treating narcolepsy with cataplexy

A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Phase 3 Interventional Takeda · NCT07363720

This study tests whether TAK-861 helps people with narcolepsy type 1 (narcolepsy with cataplexy) and whether benefits hold up after stopping the drug.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment88 (estimated)
Ages16 Years to 70 Years
SexAll
SponsorTakeda Industry-sponsored
Locations18 sites (Redwood City, California and 17 other locations)
Trial IDNCT07363720 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial gives all enrolled participants TAK-861 during an initial open-label treatment period and then randomly assigns those who meet response criteria to continue TAK-861 or switch to placebo in a double-blind randomized withdrawal for up to four weeks. About 88 participants are planned to enroll, and symptom return is monitored using measures such as the Epworth Sleepiness Scale with predefined stopping rules. Participants whose symptoms worsen during the withdrawal may stop treatment and enter a long-term extension or be followed for safety after last dose. The study also collects safety and adverse-event data and excludes people with other causes of excessive daytime sleepiness or significant cardiac, hepatic, or thyroid disease, and requires HLA-DQB1*06:02 positivity or low CSF hypocretin-1 for eligibility.

Who should consider this trial

Good fit: Ideal candidates are people with narcolepsy type 1 (narcolepsy with cataplexy) who meet the genetic or CSF hypocretin criteria (HLA-DQB1*06:02 positive or CSF hypocretin-1 ≤110 pg/mL), have a BMI of 18–40 kg/m², and can attend study visits.

Not a fit: Patients whose excessive daytime sleepiness is due to another medical disorder, or who have significant heart, liver, or thyroid disease or other listed exclusion criteria, are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, TAK-861 could reduce daytime sleepiness and cataplexy and provide sustained symptom control while on treatment, possibly supporting safer management of medication pauses.

How similar studies have performed: Randomized withdrawal designs and several existing narcolepsy medications have demonstrated benefit in past trials, but TAK-861 is a newer compound and does not yet have published Phase 3 outcome data showing success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2).
2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
3. The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\*06:02) or results from radioimmunoassay indicate the participant's CSF OX/hypocretin-1 concentration is ≤110 pg/mL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).

Exclusion Criteria:

1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
2. The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure, or c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease.
3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
4. The participant has a history of cancer in the past 5 years.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Where this trial is running

Redwood City, California and 17 other locations

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 1Narcolepsy With CataplexyDrug Therapy
Last reviewed 2026-06-13 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.