AzTrials
AzTrials

Narcolepsy Type 1Phase 3NCT06470828

A Study of TAK-861 for the Treatment of Narcolepsy Type 1

A Phase 3 study testing Oveporexton in people with Narcolepsy Type 1, run by Takeda at 53 sites in 11 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 learn how effective TAK-861 (oveporexton) is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. 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?
Oveporexton
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
53 sitesin 11 countries
Study dates
2 Jul 2024to 3 Jun 2025
Phase
Phase 3
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 has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (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 has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
  • The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)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: (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.
  • The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Trial locations and contacts

53 sites in 11 countries.

53 sites in 11 countries

United States15 sites

  • Takeda Site 3

    Atlanta, Georgia, 30328

  • Takeda Site 45

    Boston, Massachusetts, 02115

  • Takeda Site 6

    Cincinnati, Ohio, 45227

  • Takeda Site 42

    Cleveland, Ohio, 44195

  • Takeda Site 1

    Columbia, South Carolina, 29201

  • Takeda Site 44

    Dallas, Texas, 75231

  • Takeda Site 49

    Danville, Pennsylvania, 17821

  • Takeda Site 2

    Denver, North Carolina, 28037

  • Takeda Site 10

    Norfolk, Virginia, 23510

  • Takeda Site 4

    Orlando, Florida, 32803

  • Takeda Site 48

    Phoenix, Arizona, 85054

  • Takeda Site 39

    Redwood City, California, 94063

  • Takeda Site 31

    Santa Ana, California, 92705

  • Takeda Site 5

    St Louis, Missouri, 63123

  • Takeda Site 18

    Upland, California, 91786

Other trials in United States

Japan11 sites

  • Takeda Site 8

    Bunkyo-ku, Tokyo, 112-0012

  • Takeda Site 14

    Fukuoka, Fukuoka-Shi Hakata-Ku, 812-0025

  • Takeda Site 17

    Isahaya-shi, Nagasaki, 854-0081

  • Takeda Site 13

    Kitakyushu-shi, Fukuoka, 802-0084

  • Takeda Site 19

    Kodaira-shi, Tokyo, 187-8551

  • Takeda Site 9

    Kohoku, Kanagawa, 222-0033

  • Takeda Site 7

    Kumamoto, Kumamoto, 861-0954

  • Takeda Site 16

    Kurume-shi, Fukuka-Ken, 830-0011

  • Takeda Site 20

    Shibuya-ku, Tokyo, 151-0053

  • Takeda Site 15

    Urasoe-Shi, Okinawa, 901-2132

  • Takeda Site 12

    Yodogawa, Osaka, 532-0003

Other trials in Japan

Spain6 sites

  • Takeda Site 35

    Barcelona, 8035

  • Takeda Site 36

    Barcelona, O8036

  • Takeda Site 38

    Castellon, Castellon, 12004

  • Takeda Site 24

    Madrid, 28046

  • Takeda Site 41

    Valencia, 46600

  • Takeda Site 37

    Vitoria-Gasteiz, Alava, 1004

Other trials in Spain

France4 sites

  • Takeda Site 40

    Lyon, 69004

  • Takeda Site 25

    Montpellier, Herault, 34090

  • Takeda Site 29

    Paris, 75013

  • Takeda Site 43

    Toulouse, Midi-Pyrenees, 31059

Other trials in France

Canada3 sites

  • Takeda Site 50

    Montreal, Quebec, H4J 1C5

  • Takeda Site 21

    Ottawa, Ontario, K2A 3Z3

  • Takeda Site 11

    Toronto, Ontario, M5S 3A3

Other trials in Canada

Germany3 sites

  • Takeda Site 34

    Berlin, 10117

  • Takeda Site 47

    Regensberg, Bavaria, 93053

  • Takeda Site 26

    Schwerin, 19053

Other trials in Germany

Switzerland3 sites

  • Takeda Site 22

    Barmelweid, Canton of Aargau, 5017

  • Takeda Site 23

    Bern, 3010

  • Takeda Site 51

    Lugano, CH-6900

Other trials in Switzerland

United Kingdom3 sites

  • Takeda Site 46

    Cambridge, CB2 OAY

  • Takeda Site 52

    London, SE1 9RT

  • Takeda Site 53

    London, W1G 9ST

Other trials in United Kingdom

Italy2 sites

  • Takeda Site 30

    Bologna, 40139

  • Takeda Site 32

    Rome, Lazio, OO133

Other trials in Italy

Norway2 sites

  • Takeda Site 27

    Bergen, Hordaland, 5021

  • Takeda Site 33

    Oslo, 450

Other trials in Norway

Netherlands1 site

  • Takeda Site 28

    Zwolle

Other trials in Netherlands

About this study

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

The main aim of this study is to learn how effective TAK-861 (oveporexton) is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 (oveporexton) is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 (oveporexton) has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861 (oveporexton).

Read the detailed description

The drug being tested in this study is called TAK-861 (oveporexton). TAK-861 (oveporexton) is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (NT1).

The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:

  1. TAK-861 Dose 1
  2. TAK-861 Dose 2
  3. Placebo

The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.

Being tested
Oveporexton, Placebo
Keywords
Drug Therapy

What participants receive

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

  • OveporextonDrug

    Also called TAK-861

    Oral tablet.

  • PlaceboDrug

    OVE-matching placebo tablet.

Study groups in NCT06470828
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received oveporexton (OVE)-matching placebo tablets, orally, for 12 weeks.
Receives: Drug: Placebo
OVE 1 mg BIDExperimentalParticipants received OVE tablets, 1 milligram (mg), orally, for 12 weeks.
Receives: Drug: Oveporexton
OVE 2 mg BIDExperimentalParticipants received OVE tablets, 2 mg, orally, for 12 weeks.
Receives: Drug: Oveporexton

What is being measured

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

  1. Change From Baseline to Week 12 in Mean Sleep Latency From the 4 Maintenance of Wakefulness Test (MWT) Wake Trials

    The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session was recorded. Participants were required to stay awake in between the four sessions. A positive change from baseline indicates an improvement. The linear mixed effects model for repeated measures (MMRM) was used for analysis.

    Measured: Baseline, Week 12

Secondary outcomes (8)

  1. Change From Baseline to Week 12 in Epworth Sleepiness Scale (ESS) Total Score

    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. A negative change from baseline indicates an improvement. The linear MMRM was used for analysis.

    Measured: Baseline, Week 12

  2. Weekly Cataplexy Rate (WCR) at Week 12

    Participants completed a daily participant-reported cataplexy diary to record self-reported episodes of cataplexy attacks. WCR = (total number of cataplexy attacks over a number of non-missing diary days for a given period/number of non-missing diary days in that period)*7. The generalized estimating equations (GEE) model was used for analysis. Reported here is the estimated mean of incidence rate with a 95 percent (%) confidence interval (CI).

    Measured: Week 12

  3. Change From Baseline to Week 12 in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT)

    The PVT is a simple reaction performance task that aims to measure sustained attention. The mean number of lapses (delayed responses to a visual cue from intraday sessions) from the two 10-minute intraday sessions was used as a measure of objective sustained attention. A negative change from baseline indicates an improvement. A constrained Longitudinal Data Analysis (cLDA) model was used to analyze the mean number of lapses and to estimate change from baseline at each visit.

    Measured: Baseline, Week 12

  4. Responder Rate on Patient Global Impression of Change (PGI-C) Score at Week 12

    The PGI-C is a participant self-rated scale to assess change in daytime sleepiness and overall narcolepsy symptoms. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change. Responders were the participants reporting "1=very much improved" or "2=much improved" on PGI-C. Responder rate (proportion of participants who were responders) was estimated using a GEE model.

    Measured: Week 12

  5. Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score

    The NSS-CT is a 15-item self-administered questionnaire that assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disturbed nighttime sleep (DNS) with a total score range of 0 to 57 (sum of 6 items that assess symptoms severity are rated using a six-point Likert scale [0-5] and 9 items that describe the symptom effect on daily life are rated using a four-point Likert scale [0-3]). Higher total scores mean a worse outcome. A negative change from baseline indicates an improvement. The linear MMRM was used for analysis.

    Measured: Baseline, Week 12

  6. Change From Baseline to Week 12 in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores

    The FINI measures the functional impacts of narcolepsy across 6 domains Tiredness (items 1-7), Cognitive Functioning (items 8-12), Cataplexy (items 13-17), Social Activities (items 18-21), Everyday Activities (items 22-25), and Everyday Responsibilities (items 26-28). Each item asks about the impact that narcolepsy has had on their daily functioning during the past 7 days, and is scored from 0 to 4, where 0 indicates the best health and 4 the worst. An average score is calculated for each domain and then standardized to a 0-100 scale, where 0 indicates the best health and 100 the worst health. Standardized score = average score/4 × 100. A negative change from baseline indicates and improvement. The linear MMRM was used for analysis.

    Measured: Baseline, Week 12

  7. Change From Baseline to Week 12 in Short Form-36 Survey (SF-36) Mental and Physical Component Scores

    The SF-36 is participant-reported survey of participant health that assesses the quality of life and includes both physical and mental components. The scores for each component range from 0 to 100. Higher scores represent better health-related quality of life. A positive change from baseline indicates an improvement. The linear MMRM was used for analysis.

    Measured: Baseline, Week 12

  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 investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

    Measured: Up to 16 weeks

Timeline

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

  1. First posted24 Jun 2024
  2. Study start2 Jul 2024
  3. Primary completion3 Jun 2025
  4. Study completion3 Jun 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06470828
Sponsor's protocol ID
TAK-861-3001
Other IDs
2023-508465-32-00, jRCT2051240083, 2023
Status last verified
Aug 2026
First submitted
18 Jun 2024
Last updated
31 Aug 2026
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

  • Romero H, Savva Y, Crawford S, Howerter A, Dave S, Doll H. Psychometric properties of the novel patient-reported Functional Impacts of Narcolepsy Instrument (FINI) using data from phase 3 clinical trials in narcolepsy type 1. Front Neurol. 2026 Oct 15;17:1884901. doi: 10.3389/fneur.2026.1884901. eCollection 2026.

    PubMed 42959371

  • Dauvilliers Y, Mignot E, Antczak J, Arnulf I, Barateau L, Buntinx E, Corser B, Iranzo A, Khatami R, Lammers GJ, Lederer K, Nilsen KB, Pizza F, Schmidt MH, Sivam S, Sum-Ping O, Taniguchi M, Zhan S, Abraham A, Cai A, Du Y, Etherton MR, Faessel H, Hsiao S, Kadali H, Koundourakis E, Naylor M, Neuwirth R, Olsson T, Rogers R, Sheikh S, Tanaka S, von Rosenstiel P, von Hehn C, Hang Y, Yao B, Del Rio Villegas R, Plazzi G. Oveporexton for Narcolepsy Type 1 - Results from Two Phase 3 Trials. N Engl J Med. 2026 Sep 9. doi: 10.1056/NEJMoa2601598. Online ahead of print.

    PubMed 42714024

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oveporexton in people with Narcolepsy Type 1, run by Takeda at 53 sites in 11 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 7 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Japan, Spain, France, Canada and 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 31 Aug 2026). 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 to Week 12 in Mean Sleep Latency From the 4 Maintenance of Wakefulness Test (MWT) Wake Trials (time frame: Baseline, Week 12). 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 NCT06470828, 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 31 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in