Narcolepsy Type 1Phase 2/3NCT05816382
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
A Phase 2/3 study testing TAK-861 in people with Narcolepsy Type 1, run by Takeda at 52 sites in 12 countries.
Trial summary
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861. 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?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 52 sitesin 12 countries
- Study dates
- 5 Apr 2023to 28 Feb 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- 1. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
Who cannot join
- Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
- Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
- Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
Show all 11Show fewer
- Participant has epilepsy or history of seizure.
- Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
- Participant has a history of cerebral ischemia, transient ischemic attack (less than (<) 5 years ago), or cerebral hemorrhage.
- Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- Participant has a history of cancer in the past 5 years.
Trial locations and contacts
52 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 12 countries
United States19 sites, 19 recruiting
- Recruiting
Neurotrials Research
Atlanta, Georgia, 30342
- Recruiting
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
- Recruiting
Medical University of South Carolina - PPDS
Charleston, South Carolina, 29425
- Recruiting
CTI Research Center
Cincinnati, Ohio, 45212
- Recruiting
Intrepid Research
Cincinnati, Ohio, 45227
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, 80918
- Recruiting
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
- Recruiting
Research Carolina Elite
Denver, North Carolina, 28037
- Recruiting
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
- Recruiting
Georgia Neuro Center
Gainesville, Georgia, 30501
- Recruiting
ARSM Research, LLC
Huntersville, North Carolina, 28078
- Recruiting
Neurocare Inc
Newton, Massachusetts, 02459
- Recruiting
Children's Specialty Group
Norfolk, Virginia, 23510
- Recruiting
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
- Recruiting
Florida Pediatric Research Institute
Orlando, Florida, 32803
- Recruiting
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, 94063
- Recruiting
Sleep Therapy and Research Center
San Antonio, Texas, 78229
- Recruiting
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
Spain7 sites, 7 recruiting
- Recruiting
Hospital de La Ribera
Alzira, Valencia, 46600
- Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital General de Castello
Castellon, Castellon, 12004
- Recruiting
Instituto de Investigaciones del Sueno
Madrid, 28036
- Recruiting
Hospital Vithas Madrid Arturo Soria
Madrid, 28046
- Recruiting
Hospital Universitario Araba Santiago
Vitoria-Gasteiz, Alava, 01009
Japan6 sites, 6 recruiting
- Recruiting
Koishikawa Tokyo Hospital
Bunkyo-Ku, Tokyo, 112-0012
- Recruiting
Howakai Kuwamizu Hospital
Kumamoto, Kumamoto, 862-0954
- Recruiting
Kurume University Hospital
Kurume-Shi, Hukuoka, 830-0011
- Recruiting
Aichi Medical University Hospital
Nagakute, 480-1195
- Recruiting
YOU ARIYOSHI Sleep Clinic
Nagasaki, Nagasaki, 850-0045
- Recruiting
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, 532-0003
France4 sites, 4 recruiting
- Recruiting
CHU de Grenoble
La Tronche, Isere, 38700
- Recruiting
CHU Gui De Chauliac
Montpellier, Herault, 34090
- Recruiting
Hopital de la Pitie Salpetriere
Paris, 75013
- Recruiting
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne, 31000
Germany4 sites, 4 recruiting
- Recruiting
Charite - Universitatsmedizin Berlin
Berlin, 10117
- Recruiting
Klinische Forschung Hamburg
Hamburg, 20253
- Recruiting
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bavaria, 93053
- Recruiting
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19053
Italy3 sites, 3 recruiting
- Recruiting
Ospedale Bellaria
Bellaria, 40139
- Recruiting
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, 86077
- Recruiting
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133
Switzerland3 sites, 3 recruiting
- Recruiting
Klinik Barmelweid AG
Barmelweid, Aargau (de), 5017
- Recruiting
Universitaetsspital Bern - Inselspital
Bern, 43017-3521
- Recruiting
Neurocenter of Southern Switzerland
Lugano, Ticino (it), 6900
Netherlands2 sites, 2 recruiting
- Recruiting
Slaap-Waakcentrum SEIN Heemstede
Heemstede, North Holland, 2103 SW
- Recruiting
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE
Australia1 site, 1 recruiting
- Recruiting
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037
Finland1 site, 1 recruiting
- Recruiting
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa, 00380
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 46
About this study
Official title: A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Read the detailed description
The drug being tested in this trial is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This trial will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.
This trial was initiated in parallel with the parent phase 2 trials, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) trial enrolled participants with both diagnoses from the two phase 2 trials. As the TAK-861-2002 trial did not meet prespecified criteria, all participants with NT2 were discontinued, and moving forward this extension study only includes participants with NT1 who previously completed a parent trial. Parent trials include all TAK-861 phase 3 trials in addition to the phase 2 trial participants from TAK-861-2001.
The trial will enroll up to 500 participants. All participants in the trial will receive TAK-861. Participants who were previously on a placebo dose will be assigned to one of the TAK-861 doses randomly.
This multi-center trial will be conducted worldwide. Study period is approximately 5 years or until the study is stopped at the sponsor's discretion, or the product is approved and launched. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health) and will have a follow-up assessment 4 weeks after the last dose of trial intervention.
- Conditions
- Narcolepsy Type 1
- Being tested
- TAK-861
- 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 tablets
| Study group | Role | What they receive |
|---|---|---|
| TAK-861 | Experimental | In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed. Receives: Drug: TAK-861 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., 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 is defined as an adverse event with an onset that occurs after receiving trial intervention.
Measured: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)
Secondary outcomes (3)
Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the 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 done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Measured: Baseline (parent trial), Week 26 (current LTE trial)
Change from Baseline in the Parent Trial 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, and scores below 10 are considered to be within the normal range.
Measured: Baseline (parent trial); Week 2 through Year 5 (current LTE trial)
Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary
Participants will record episodes of cataplexy in the diary throughout the trial.
Measured: Baseline (parent trial); Year 1 through Year 5 (current LTE trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start5 Apr 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816382
- Sponsor's protocol ID
- TAK-861-2003
- Other IDs
- U1111-1283-1888, jRCT2031230135, 2023-508462-15-00, 2023
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
- ClinicalTrials.gov ID
- NCT05816382
- Acronym / sponsor ID
- TAK-861-2003
- Conditions
- Narcolepsy Type 1
- Keywords
- Drug Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Detailed description
The drug being tested in this trial is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This trial will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.
This trial was initiated in parallel with the parent phase 2 trials, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) trial enrolled participants with both diagnoses from the two phase 2 trials. As the TAK-861-2002 trial did not meet prespecified criteria, all participants with NT2 were discontinued, and moving forward this extension study only includes participants with NT1 who previously completed a parent trial. Parent trials include all TAK-861 phase 3 trials in addition to the phase 2 trial participants from TAK-861-2001.
The trial will enroll up to 500 participants. All participants in the trial will receive TAK-861. Participants who were previously on a placebo dose will be assigned to one of the TAK-861 doses randomly.
This multi-center trial will be conducted worldwide. Study period is approximately 5 years or until the study is stopped at the sponsor's discretion, or the product is approved and launched. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health) and will have a follow-up assessment 4 weeks after the last dose of trial intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-861 | Experimental | Drug: TAK-861In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
Key exclusion criteria (11 listed)
- Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (>) 1.5 times the upper limit of normal (ULN).
- Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
- Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-861TAK-861 tablets | Drug | TAK-861 |
Primary outcome
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., 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 is defined as an adverse event with an onset that occurs after receiving trial intervention.
3 secondary outcomes
Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Time frame: Baseline (parent trial), Week 26 (current LTE trial)
Change from Baseline in the Parent Trial in Epworth Sleepiness Scale (ESS) Total Score
Time frame: Baseline (parent trial); Week 2 through Year 5 (current LTE trial)
Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary
Time frame: Baseline (parent trial); Year 1 through Year 5 (current LTE trial)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
52 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TAK-861 in people with Narcolepsy Type 1, run by Takeda at 52 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Spain, Japan, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) (time frame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.