A Study of TAK-861 in Participants With Narcolepsy Type 2

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).

The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Study Overview

• Status: Completed
• Conditions: Narcolepsy Type 2
• Intervention / Treatment: Drug: Placebo; Drug: TAK-861 2 mg; Drug: TAK-861 2 mg and 5 mg

Detailed Description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy [Narcolepsy Type 2 (NT2)]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861.

The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• TAK-861 Dose 1
• TAK-861 Dose 2
• Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Glebe, New South Wales, Australia, 2037
      • Woolcock Institute of Medical Research
• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00380
      • Terveystalo Helsinki Sleep Clinic
• France
  • Paris, France, 75013
    • Hôpital de la Pitié Salpêtrière
  • Herault
    • Montpellier, Herault, France, 34090
      • Hopital Saint-Eloi
  • Isere
    • La Tronche, Isere, France, 38700
      • CHU de Grenoble
• Germany
  • Berlin, Germany, 10117
    • Advanced Sleep Research GmbH
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
      • Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
• Italy
  • Bellaria, Italy, 40139
    • IRCCS Istituto delle Scienze Neurologiche di Bologna
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Fondazione PTV Policlinico Tor Vergata
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • Istituto Neurologico Mediterraneo Neuromed
• Japan
  • Nagakute, Japan, 480-1195
    • Aichi Medical University Hospital
  • Yokohama, Japan, 222-0033
    • RESM respiratory and sleep medical-care clinic
  • Akita
    • Akita-Shi, Akita, Japan, 010-8543
      • Akita University Hospital
  • Ehime
    • Toon-Shi, Ehime, Japan, 791-0295
      • Ehime University Hospital
  • Hukuoka
    • Kitakyushu-city, Hukuoka, Japan, 806-0021
      • YOU ARIYOSHI Sleep Clinic
    • Kurume-Shi, Hukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Kumamoto
    • Kumamoto-Shi, Kumamoto, Japan, 862-0954
      • Howakai Kuwamizu Hospital
  • Osaka
    • Osaka-Shi, Osaka, Japan, 532-0003
      • Gokeikai Osaka Kaisei Hospital
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 112-0012
      • Koishikawa Tokyo Hospital
    • Kodaira-Shi, Tokyo, Japan, 187-8551
      • National Center of Neurology and Psychiatry
    • Shibuya-Ku, Tokyo, Japan, 151-0053
      • Yoyogi Sleep Disorder Center
• Netherlands
  • Noord-Brabant
    • Heeze, Noord-Brabant, Netherlands, 5591 VE
      • Kempenhaeghe - PPDS
  • Noord-Holland
    • Heemstede, Noord-Holland, Netherlands, 2103 SW
      • Slaap-Waakcentrum SEIN Heemstede
• Norway
  • Oslo, Norway, 0450
    • Oslo Universitetssykehus HF Rikshospitalet
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28036
    • Instituto de Investigaciones del Sueño
  • Madrid, Spain, 28043
    • Hospital Vithas Madrid Arturo Soria
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 1004
      • Hospital Universitario Araba Santiago
  • Castellon
    • Castellón De La Plana, Castellon, Spain, 12004
      • Hospital General Universitari de Castelló
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Hospital de La Ribera
• Sweden
  • Vastra Gotalands Lan
    • Goteborg, Vastra Gotalands Lan, Sweden, 413 90
      • Sahlgrenska Universitetssjukhuset
• Switzerland
  • Bern, Switzerland, 3010
    • Universitaetsspital Bern - Inselspital
  • Aargau (de)
    • Barmelweid, Aargau (de), Switzerland, 5017
      • Klinik Barmelweid AG
  • Ticino (it)
    • Lugano, Ticino (it), Switzerland, 6900
      • Neurocenter of Southern Switzerland
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213-1966
      • Sleep Disorders Center of Alabama
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5452
      • Mayo Clinic Arizona-PPDS
  • California
    • Redwood City, California, United States, 94063
      • Stanford Center for Sleep Sciences and Medicine
    • Santa Ana, California, United States, 92705-8519
      • SDS Clinical Trials, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves LLC - Hunt - PPDS
  • Florida
    • Orlando, Florida, United States, 32803-1468
      • Florida Pediatric Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342-1743
      • NeuroTrials Research
    • Gainesville, Georgia, United States, 30501-3883
      • Georgia Neuro Center
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Neurocare Inc.
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Medical Center - Columbus
  • Missouri
    • Chesterfield, Missouri, United States, 63017-3406
      • St. Lukes Sleep Medicine and Research Center
  • North Carolina
    • Denver, North Carolina, United States, 28037
      • Research Carolina Elite
    • Huntersville, North Carolina, United States, 28078-5082
      • ARSM Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Tricoastal Narcolepsy and Sleep Disorders Center, PLLC
    • Cincinnati, Ohio, United States, 45227-2172
      • Intrepid Research
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Dublin, Ohio, United States, 43017-3521
      • Ohio Sleep Medicine Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29425-5712
      • Medical University of South Carolina - PPDS
    • Columbia, South Carolina, United States, 29201-2923
      • Bogan Sleep Consultants, LLC
  • Texas
    • Houston, Texas, United States, 77030-2042
      • Comprehensive Sleep Medicine Associates - Sugar Land
    • San Antonio, Texas, United States, 78229-4849
      • Sleep Therapy and Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23510-1021
      • Children's Specialty Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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 an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.

Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.

Exclusion Criteria:

• The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
• 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:

  1. Any current unstable psychiatric disorder.
  2. 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, mental retardation, 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).
  3. Current diagnosis or history of substance use disorder as defined in the DSM-5. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
  4. 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 had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.	Drug: Placebo; TAK-861 placebo matching tablets.
Experimental: TAK-861 2 milligrams (mg) BID; Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.	Drug: TAK-861 2 mg; TAK-861 2 mg tablets.
Experimental: TAK-861 2 mg and 5 mg; Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.	Drug: TAK-861 2 mg and 5 mg; TAK-861 2 mg and 5 mg tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8	The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. 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 the normal range. The MMRM was used for analysis.	Baseline, Week 8
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug.	From first dose of the study drug up to end of the study (up to 3 months)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: TAK-861-2002; 2022-002966-34 (EudraCT Number); jRCT2031230050 (Registry Identifier: jRCT); U1111-1282-8382 (Other Identifier: WHO Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No