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Narcolepsy Type 2Phase 2NCT05687916

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

A Phase 2 study testing TAK-861 2 mg and TAK-861 2 mg and 5 mg in people with Narcolepsy Type 2, run by Takeda at 56 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 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). Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Narcolepsy Type 2
What is being tested?
TAK-861 2 mg and TAK-861 2 mg and 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
56 sitesin 12 countries
Study dates
9 Jan 2023to 25 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 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.

Who cannot join

  • 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:
  • 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, 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).
  • 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.)
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  • 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.

Trial locations and contacts

56 sites in 12 countries.

56 sites in 12 countries

United States22 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

  • Tricoastal Narcolepsy and Sleep Disorders Center, PLLC

    Cincinnati, Ohio, 45212

  • Intrepid Research

    Cincinnati, Ohio, 45227-2172

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Delta Waves LLC - Hunt - PPDS

    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

  • Neurocare Inc.

    Newton, Massachusetts, 02459

  • 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

  • Sleep Therapy and Research Center

    San Antonio, Texas, 78229-4849

  • SDS Clinical Trials, Inc.

    Santa Ana, California, 92705-8519

  • Mayo Clinic Arizona-PPDS

    Scottsdale, Arizona, 85259-5452

Other trials in United States

Japan11 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Koishikawa Tokyo Hospital

    Bunkyo-Ku, Tokyo, 112-0012

  • You Ariyoshi Sleep Clinic

    Kitakyushu, Hukuoka, 806-0021

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo, 187-8551

  • Howakai Kuwamizu Hospital

    Kumamoto, Kumamoto, 862-0954

  • Kurume University Hospital

    Kurume-Shi, Hukuoka, 830-0011

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Gokeikai Osaka Kaisei Hospital

    Osaka, Osaka, 532-0003

  • Yoyogi Sleep Disorder Center

    Shibuya-Ku, Tokyo, 151-0053

  • Ehime University Hospital

    Toon-Shi, Ehime, 791-0295

  • RESM respiratory and sleep medical-care clinic

    Yokohama, 222-0033

Other trials in Japan

Spain6 sites

  • Hospital de La Ribera

    Alzira, Valencia, 46600

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General Universitari de Castello

    Castellon, Castellon, 12004

  • Instituto de Investigaciones del Sueno

    Madrid, 28036

  • Hospital Vithas Madrid Arturo Soria

    Madrid, 28043

  • Hospital Universitario Araba Santiago

    Vitoria-Gasteiz, Alava, 1004

Other trials in Spain

France3 sites

  • CHU de Grenoble

    La Tronche, Isere, 38700

  • Hopital Saint-Eloi

    Montpellier, Herault, 34090

  • Hopital de la Pitie Salpetriere

    Paris, 75013

Other trials in France

Italy3 sites

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bellaria, 40139

  • Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Molise, 86077

  • Fondazione PTV Policlinico Tor Vergata

    Rome, Lazio, 00133

Other trials in Italy

Switzerland3 sites

  • Klinik Barmelweid AG

    Barmelweid, Aargau (de), 5017

  • Universitaetsspital Bern - Inselspital

    Bern, 3010

  • Neurocenter of Southern Switzerland

    Lugano, Ticino (it), 6900

Other trials in Switzerland

Germany2 sites

  • Advanced Sleep Research GmbH

    Berlin, 10117

  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern, 19053

Other trials in Germany

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

    Glebe, New South Wales, 2037

Other trials in Australia

Finland1 site

  • Terveystalo Helsinki Sleep Clinic

    Helsinki, Uusimaa, 00380

Other trials in Finland

Norway1 site

  • Oslo Universitetssykehus HF Rikshospitalet

    Oslo, 0450

Other trials in Norway

Sweden1 site

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götaland County, 413 90

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 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.

Read the 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.

Being tested
Placebo, TAK-861 2 mg, TAK-861 2 mg and 5 mg
Keywords
Drug Therapy

What participants receive

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

  • PlaceboDrug

    TAK-861 placebo matching tablets.

  • TAK-861 2 mgDrug

    TAK-861 2 mg tablets.

  • TAK-861 2 mg and 5 mgDrug

    TAK-861 2 mg and 5 mg tablets.

Study groups in NCT05687916
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 2 milligrams (mg) BIDExperimentalParticipants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
Receives: Drug: TAK-861 2 mg
TAK-861 2 mg and 5 mgExperimentalParticipants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
Receives: Drug: TAK-861 2 mg and 5 mg

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 (2)

  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. 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.

    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 completion13 Dec 2023
  4. Study completion25 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, Investigator
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687916
Sponsor's protocol ID
TAK-861-2002
Other IDs
2022-002966-34, U1111-1282-8382, jRCT2031230050
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-861 2 mg and TAK-861 2 mg and 5 mg in people with Narcolepsy Type 2, run by Takeda at 56 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 4 inclusion and 9 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 56 sites in United States, Japan, Spain, France, Italy 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 NCT05687916.

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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