A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

NCT07363720 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: TAK-861-30032024-519466-44-00
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 7

Brief Summary

The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.

Conditions

Narcolepsy Type 1 (NT1); Narcolepsy With Cataplexy

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Time to Loss of Response in the Epworth Sleepiness Scale (ESS) Score During the Up to 4-Week RW Period

  The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within normal range.

  Up to 4-week RW period

Secondary Outcomes (8)

• Change From the End of the OL Treatment Period to Week 2 of the RW Period on the Maintenance of Wakefulness Test (MWT)

  From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)

• Weekly Cataplexy Rate (WCR) at Week 2 of the RW Period

  Week 2 of the RW period

• Change from the End of the OL Treatment Period to Week 2 of the RW Period in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT)

  From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)

• Number of Participants Reporting Much or Very Much Worse in Patient Global Impression of Change (PGI-C) Score at Week 2 of the RW Period

  Week 2 of the RW period

• Change from the End of the OL Treatment Period to Week 2 of the RW Period in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score

  From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)

Study Arms (2)

Double-blind RW Period: TAK-861

EXPERIMENTAL

Participants on stable TAK 861 dose will receive the same dose of TAK-861 they were taking at the end of the OL treatment period, for up to 4 weeks in the double-blind RW period.

Drug: TAK-861

Double-blind RW Period: Placebo

PLACEBO COMPARATOR

Participants will receive TAK-861 matching-placebo, for up to 4 weeks in the double-blind RW period.

Drug: Placebo

Interventions

TAK-861 DRUG

TAK-861 tablets

Double-blind RW Period: TAK-861

Placebo DRUG

TAK-861-matching placebo tablets

Double-blind RW Period: Placebo

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^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.
• 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).

You may not qualify if:

• The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
• 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.
• The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
• The participant has a history of cancer in the past 5 years.
• The participant has a clinically significant history of head injury or head trauma.
• The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
• The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

Takeda Site 1

Redwood City, California, 94063, United States

RECRUITING

Takeda Site 4

Brandon, Florida, 33511, United States

RECRUITING

Takeda Site 6

Miami, Florida, 33155, United States

RECRUITING

Takeda Site 7

Southfield, Michigan, 48075, United States

RECRUITING

Takeda Site 2

Cincinnati, Ohio, 45245, United States

RECRUITING

Takeda Site 3

Columbia, South Carolina, 29201, United States

RECRUITING

Takeda Site 5

Austin, Texas, 78731, United States

RECRUITING

Related Links

• To obtain more information on the study, click here/on this link.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (7)