A Study of TAK-861 in Participants With Narcolepsy Type 1

NCT05687903 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: TAK-861-20012022-001654-38U1111-1277-4261jRCT2031220644
• Study Type: interventional
• Target: 112
• Locations: 12 countries
• Sites: 57

Brief Summary

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

Conditions

Narcolepsy Type 1

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8

  The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.

  Baseline, Week 8

Secondary Outcomes (3)

• Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8

  Baseline, Week 8

• Weekly Cataplexy Rate (WCR) at Week 8

  Week 8

• Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

  From first dose of the study drug up to end of the study (up to 3 months)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.

Drug: Placebo

TAK-861 0.5 mg BID

EXPERIMENTAL

Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.

Drug: TAK-861

TAK-861 2 mg BID

EXPERIMENTAL

Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

Drug: TAK-861

TAK-861 2 mg and 5 mg

EXPERIMENTAL

Participants received TAK-861 2 mg followed by 5 mg dose, orally, BID, from Days 1 to 56.

Drug: TAK-861

TAK-861 7 mg QD

EXPERIMENTAL

Participants received TAK-861 7 mg, orally, once daily (QD), from Day 1 to 56. Placebo was given as the second dose.

Drug: TAK-861; Drug: Placebo

Interventions

TAK-861 DRUG

TAK-861 oral tablets

TAK-861 0.5 mg BID; TAK-861 2 mg BID; TAK-861 2 mg and 5 mg; TAK-861 7 mg QD

Placebo DRUG

Placebo oral tablets matching TAK-861

Placebo; TAK-861 7 mg QD

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 is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
• Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
• The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter \[kg/m\^2\] (inclusive).
• The participant has an International Classification of Sleep Disorders, 3rd Edition (ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep Latency Test (MSLT), performed within the past 10 years.
• The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from cerebrospinal fluid (CSF) testing indicate the participant's CSF orexin (OX)/hypocretin-1 concentration is \<110 picograms per milliliter (\[pg/mL\] (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 has medically significant hepatic or thyroid disease.
• The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell cancer).
• The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
• The participant has a clinically significant history of head injury or head trauma.
• The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
• The participant has one or more of the following psychiatric disorders:
• Any current unstable psychiatric disorder.
• Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, intellectual disability, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
• Current diagnosis or history of substance use disorder as defined in the DSM-5.
• Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
• The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years ago), intracranial aneurysm, or arteriovenous malformation.
• The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen.
• The participant's renal creatinine clearance (Cockcroft-Gault Equation) is ≤50 mL/minute.
• The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>1.5 times the upper limit of normal (ULN).

Sponsors & Collaborators

• Takeda: lead

Study Sites (57)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213-1966, United States

Location

Stanford Center for Sleep Sciences and Medicine

Redwood City, California, 94063-3132, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705-8519, United States

Location

Delta Waves LLC - Hunt - PPDS, Sleep Disorder and Research Center

Colorado Springs, Colorado, 80918, United States

Location

Florida Pediatric Research Institute

Orlando, Florida, 32803-1468, United States

Location

Neurotrials Research

Atlanta, Georgia, 30342-1743, United States

Location

Georgia Neuro Center

Gainesville, Georgia, 30501-3883, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160-0001, United States

Location

Neurocare Inc

Newton, Massachusetts, 02459-3233, United States

Location

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Location

St. Lukes Sleep Medicine and Research Center

Chesterfield, Missouri, 63017-3406, United States

Location

Research Carolina Elite

Denver, North Carolina, 28037, United States

Location

ARSM Research, LLC

Huntersville, North Carolina, 28078-5082, United States

Location

Intrepid Research

Cincinnati, Ohio, 45227-2172, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195-0001, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017-3521, United States

Location

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425-5712, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201-2923, United States

Location

Comprehensive Sleep Medicine Associates - Sugar Land

Houston, Texas, 77030-2042, United States

Location

Sleep Therapy and Research Center

San Antonio, Texas, 78229-4849, United States

Location

Children's Specialty Group

Norfolk, Virginia, 23510-1021, United States

Location

Woolcock Institute of Medical Research, Sleep and Circadian Research Group

Glebe, New South Wales, 2037, Australia

Location

Terveystalo Helsinki Sleep Clinic

Helsinki, Uusimaa, 00380, Finland

Location

Hopital Pierre-Paul Riquet

Toulouse, Haute-Garonne, 31000, France

Location

CHU Gui De Chauliac

Montpellier, Herault, 34090, France

Location

CHU de Grenoble

La Tronche, Isere, 38700, France

Location

Hopital de la Pitie Salpetriere

Paris, 75013, France

Location

Universitaet Regensburg am Bezirksklinikum

Regensburg, Bavaria, 93053, Germany

Location

Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

Charite - Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Klinische Forschung Hamburg

Hamburg, 20253, Germany

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna, Dipartimento di Scienze Biomediche e Neuromotorie

Bellaria, Bologna, 40139, Italy

Location

Fondazione PTV Policlinico Tor Vergata, Centro del Sonno e del Trattamento Neurologico delle Fragilta

Rome, Lazio, 00133, Italy

Location

Istituto Neurologico Mediterraneo Neuromed, Centro Per La Diagnosi E la Cura Del Sonno

Pozzilli, Molise, 86077, Italy

Location

Akita University Hospital

Akita, Akita, 010-8543, Japan

Location

Kurume University Hospital

Kurume-Shi, Hukuoka, 830-0011, Japan

Location

Howakai Kuwamizu Hospital, Chuo-Ku

Kumamoto, Kumamoto, 862-0954, Japan

Location

Gokeikai Osaka Kaisei Hospital, Yodogawa-Ku

Osaka, Osaka, 532-0003, Japan

Location

Koishikawa Tokyo Hospital

Bunkyo-Ku, Tokyo, 112-0012, Japan

Location

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, 187-8551, Japan

Location

Yoyogi Sleep Disorder Center

Shibuya-Ku, Tokyo, 151-0053, Japan

Location

Aichi Medical University Hospital

Nagakute, 480-1195, Japan

Location

RESM respiratory and sleep medical-care clinic, Yokoharna Building, 4Floor

Yokohama, 222-0033, Japan

Location

Kempenhaeghe - PPDS

Heeze, North Brabant, 5591 VE, Netherlands

Location

Slaap-Waakcentrum SEIN Heemstede

Heemstede, North Holland, 2103 SW, Netherlands

Location

University of Oslo

Oslo, 0450, Norway

Location

Hospital Universitario Araba Santiago, Unidad Funcional de Sueno

Vitoria-Gasteiz, Alava, 01004, Spain

Location

Hospital General de Castello, Sleep Unit

Castellon, Castellon, 12004, Spain

Location

Hospital de La Ribera, Unidad de Sueno

Alzira, Valencia, 46600, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona, Neurology Service, scale 8-4th floor

Barcelona, 08036, Spain

Location

Instituto de Investigaciones del Sueno

Madrid, 28036, Spain

Location

Hospital Vithas Madrid Arturo Soria

Madrid, 28046, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

Klinik Barmelweid AG

Barmelweid, Aargau (de), 5017, Switzerland

Location

Neurocenter of Southern Switzerland

Lugano, Ticino (it), 6900, Switzerland

Location

Universitaetsspital Bern, Department of Neurology

Bern, 3010, Switzerland

Location

Related Publications (2)

• Lammers GJ, Plazzi G, Mignot E, Pizza F, Dauvilliers Y, Barateau L, Maruff P, Scammell TE, Latzman RD, Naylor M, Olsson T, Stukalin E, Tanaka S, Volfson D, Khachadourian V, Harel BT. Effects of Oveporexton, an Orexin Receptor 2-Selective Agonist, on Cognition in Narcolepsy Type 1: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2025 Dec 8:e254825. doi: 10.1001/jamaneurol.2025.4825. Online ahead of print.

  PMID: 41359331 DERIVED

• Dauvilliers Y, Plazzi G, Mignot E, Lammers GJ, Del Rio Villegas R, Khatami R, Taniguchi M, Abraham A, Hang Y, Kadali H, Lamberton M, Sheikh S, Stukalin E, Neuwirth R, Swick TJ, Tanaka S, von Hehn C, von Rosenstiel P, Wang H, Cai A, Naylor M, Olsson T. Oveporexton, an Oral Orexin Receptor 2-Selective Agonist, in Narcolepsy Type 1. N Engl J Med. 2025 May 15;392(19):1905-1916. doi: 10.1056/NEJMoa2405847.

  PMID: 40367374 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: January 9, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

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

IT (3); SE (1); US (21); DE (4); NO (1); CH (3); FR (4); FI (1); JP (9); ES (7); AU (1); NL (2)