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Narcolepsy Type 1Phase 2NCT05687903

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

A Phase 2 study testing TAK-861 in people with Narcolepsy Type 1, run by Takeda at 57 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Narcolepsy Type 1
What is being tested?
TAK-861
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
57 sitesin 12 countries
Study dates
9 Jan 2023to 14 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
Show all 16Show fewer
  • 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).
  • The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year.

Trial locations and contacts

57 sites in 12 countries.

57 sites in 12 countries

United States21 sites

  • Neurotrials Research

    Atlanta, Georgia, 30342-1743

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213-1966

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina, 29425-5712

  • St. Lukes Sleep Medicine and Research Center

    Chesterfield, Missouri, 63017-3406

  • Intrepid Research

    Cincinnati, Ohio, 45227-2172

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195-0001

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

    Colorado Springs, Colorado, 80918

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201-2923

  • Research Carolina Elite

    Denver, North Carolina, 28037

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017-3521

  • Georgia Neuro Center

    Gainesville, Georgia, 30501-3883

  • Comprehensive Sleep Medicine Associates - Sugar Land

    Houston, Texas, 77030-2042

  • ARSM Research, LLC

    Huntersville, North Carolina, 28078-5082

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160-0001

  • Neurocare Inc

    Newton, Massachusetts, 02459-3233

  • Children's Specialty Group

    Norfolk, Virginia, 23510-1021

  • Henry Ford Medical Center - Columbus

    Novi, Michigan, 48377

  • Florida Pediatric Research Institute

    Orlando, Florida, 32803-1468

  • Stanford Center for Sleep Sciences and Medicine

    Redwood City, California, 94063-3132

  • Sleep Therapy and Research Center

    San Antonio, Texas, 78229-4849

  • SDS Clinical Trials, Inc.

    Santa Ana, California, 92705-8519

Other trials in United States

Japan9 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Koishikawa Tokyo Hospital

    Bunkyo-Ku, Tokyo, 112-0012

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo, 187-8551

  • Howakai Kuwamizu Hospital, Chuo-Ku

    Kumamoto, Kumamoto, 862-0954

  • Kurume University Hospital

    Kurume-Shi, Hukuoka, 830-0011

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Gokeikai Osaka Kaisei Hospital, Yodogawa-Ku

    Osaka, Osaka, 532-0003

  • Yoyogi Sleep Disorder Center

    Shibuya-Ku, Tokyo, 151-0053

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

    Yokohama, 222-0033

Other trials in Japan

Spain7 sites

  • Hospital de La Ribera, Unidad de Sueno

    Alzira, Valencia, 46600

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

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

    Barcelona, 08036

  • Hospital General de Castello, Sleep Unit

    Castellon, Castellon, 12004

  • Instituto de Investigaciones del Sueno

    Madrid, 28036

  • Hospital Vithas Madrid Arturo Soria

    Madrid, 28046

  • Hospital Universitario Araba Santiago, Unidad Funcional de Sueno

    Vitoria-Gasteiz, Alava, 01004

Other trials in Spain

France4 sites

  • CHU de Grenoble

    La Tronche, Isere, 38700

  • CHU Gui De Chauliac

    Montpellier, Herault, 34090

  • Hopital de la Pitie Salpetriere

    Paris, 75013

  • Hopital Pierre-Paul Riquet

    Toulouse, Haute-Garonne, 31000

Other trials in France

Germany4 sites

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117

  • Klinische Forschung Hamburg

    Hamburg, 20253

  • Universitaet Regensburg am Bezirksklinikum

    Regensburg, Bavaria, 93053

  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern, 19053

Other trials in Germany

Italy3 sites

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

    Bellaria, Bologna, 40139

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

    Pozzilli, Molise, 86077

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

    Rome, Lazio, 00133

Other trials in Italy

Switzerland3 sites

  • Klinik Barmelweid AG

    Barmelweid, Aargau (de), 5017

  • Universitaetsspital Bern, Department of Neurology

    Bern, 3010

  • Neurocenter of Southern Switzerland

    Lugano, Ticino (it), 6900

Other trials in Switzerland

Netherlands2 sites

  • Slaap-Waakcentrum SEIN Heemstede

    Heemstede, North Holland, 2103 SW

  • Kempenhaeghe - PPDS

    Heeze, North Brabant, 5591 VE

Other trials in Netherlands

Australia1 site

  • Woolcock Institute of Medical Research, Sleep and Circadian Research Group

    Glebe, New South Wales, 2037

Other trials in Australia

Finland1 site

  • Terveystalo Helsinki Sleep Clinic

    Helsinki, Uusimaa, 00380

Other trials in Finland

Norway1 site

  • University of Oslo

    Oslo, 0450

Other trials in Norway

Sweden1 site

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götaland County, 413 46

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

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.

Read the detailed description

The drug being tested in this study is called TAK-861. This study will look at the effect of TAK-861 on improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.

The study will enroll approximately 100 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • TAK-861 Dose 1
  • TAK-861 Dose 2
  • TAK-861 Dose 3
  • TAK-861 Dose 4
  • Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 23 weeks. Participants will make multiple visits to the clinic during the treatment period and then will either enroll in a long-term extension study in which all participants will receive TAK-861 or have 2 final visits 7 and 28 days after last dose of study drug for follow-up assessments.

Being tested
TAK-861, Placebo
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-861Drug

    TAK-861 oral tablets

  • PlaceboDrug

    Placebo oral tablets matching TAK-861

Study groups in NCT05687903
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
Receives: Drug: Placebo
TAK-861 0.5 mg BIDExperimentalParticipants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.
Receives: Drug: TAK-861
TAK-861 2 mg BIDExperimentalParticipants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
Receives: Drug: TAK-861
TAK-861 2 mg and 5 mgExperimentalParticipants received TAK-861 2 mg followed by 5 mg dose, orally, BID, from Days 1 to 56.
Receives: Drug: TAK-861
TAK-861 7 mg QDExperimentalParticipants received TAK-861 7 mg, orally, once daily (QD), from Day 1 to 56. Placebo was given as the second dose.
Receives: Drug: TAK-861; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 8

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, Week 8

  2. Weekly Cataplexy Rate (WCR) at Week 8

    Participants completed a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants recorded episodes of cataplexy attacks in the diary. The total number of events averaged for a week were reported. WCR = (total number of cataplexy attacks over a number of non-missing diary days for a given duration/number of non-missing diary days in that duration)*7. The generalized estimating equations (GEE) model was used for analysis.

    Measured: Week 8

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

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence was 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 with an onset that occurred after receiving study drug.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start9 Jan 2023
  3. Primary completion14 Dec 2023
  4. Study completion14 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687903
Sponsor's protocol ID
TAK-861-2001
Other IDs
2022-001654-38, U1111-1277-4261, jRCT2031220644
Status last verified
Dec 2024
First submitted
9 Jan 2023
Last updated
9 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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. 2026 Feb 1;83(2):145-152. doi: 10.1001/jamaneurol.2025.4825.

    PubMed 41359331

  • 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.

    PubMed 40367374

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-861 in people with Narcolepsy Type 1, run by Takeda at 57 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Japan, Spain, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687903, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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