Narcolepsy Type 2Phase 2NCT06952699
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
A Phase 2 study testing TAK-360 in people with Narcolepsy Type 2, run by Takeda at 52 sites in 7 countries.
Trial summary
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 2
- What is being tested?
- TAK-360
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 52 sitesin 7 countries
- Study dates
- 6 May 2025to 30 Nov 2026
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].
- The participant has a documented, current diagnosis of NT2.
Who cannot join
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
- The participant has medically significant thyroid disease.
- The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
- The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
- The participant has a clinically significant history of head injury or head trauma.
- The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Trial locations and contacts
52 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 7 countries
United States31 sites, 25 recruiting
- Recruiting
Takeda Site 32
Atlanta, Georgia, 30328
- Active, not recruiting
Takeda Site 36
Auburn, Alabama, 36832
- Recruiting
Takeda Site 38
Austin, Texas, 78731
- Recruiting
Takeda Site 49
Bowie, Maryland, 20715
- Recruiting
Takeda Site 48
Bradenton, Florida, 34209
- Recruiting
Takeda Site 13
Brandon, Florida, 33511-5719
- Withdrawn
Takeda Site 39
Chandler, Arizona, 85224
- Recruiting
Takeda Site 40
Chula Vista, California, 91910
- Recruiting
Takeda Site 5
Cincinnati, Ohio, 45245-4500
- Recruiting
Takeda Site 45
Cleveland, Ohio, 44106
- Recruiting
Takeda Site 1
Colorado Springs, Colorado, 80918-3408
- Recruiting
Takeda Site 2
Columbia, South Carolina, 29201-2923
- Withdrawn
Takeda Site 43
Dallas, Texas, 75235
- Recruiting
Takeda Site 8
Denver, North Carolina, 28037
- Completed
Takeda Site 42
El Paso, Texas, 79912
- Recruiting
Takeda Site 6
Huntersville, North Carolina, 28078-5082
- Recruiting
Takeda Site 46
Jacksonville, Florida, 32209
- Recruiting
Takeda Site 50
Lansing, Michigan, 48911
- Recruiting
Takeda Site 34
Lathrup Village, Michigan, 48076
- Withdrawn
Takeda Site 47
Mansfield, Texas, 76063
- Recruiting
Takeda Site 44
Miami, Florida, 33155
- Recruiting
Takeda Site 35
Miami, Florida, 33176
- Recruiting
Takeda Site 37
Middletown, New Jersey, 07748
- Recruiting
Takeda Site 11
Norfolk, Virginia, 23510-1021
- Recruiting
Takeda Site 3
Orlando, Florida, 32803-1468
- Active, not recruiting
Takeda Site 33
Orlando, Florida, 32807
- Recruiting
Takeda Site 14
Redwood City, California, 94063-3132
- Recruiting
Takeda Site 7
San Antonio, Texas, 78229-4849
- Recruiting
Takeda Site 10
Santa Ana, California, 92705-8519
- Recruiting
Takeda Site 4
St Louis, Missouri, 63123-6968
- Recruiting
Takeda Site 41
Winston-Salem, North Carolina, 27103
Japan8 sites, 7 recruiting
- Recruiting
Takeda Site 52
Fukuoka, 812-0025
- Recruiting
Takeda Site 53
Isahaya-shi, Nagasaki, 854-0081
- Recruiting
Takeda Site 24
Kohoku-ku, Yokohama-Shi, Kanagawa, 222-0033
- Recruiting
Takeda Site 9
Kumamoto, Kumamoto, 862-0954
- Recruiting
Takeda Site 20
Shinjuku-ku, Tokyo, 162-0851
- Recruiting
Takeda Site 26
Sumida-Ku, Tokyo, 130-0004
- Recruiting
Takeda Site 30
Urasoe-Shi, Okinawa, 901-2132
- Active, not recruiting
Takeda Site 12
Yodogawa-ku, Osaka-shi, Ôsaka, 532-0003
China4 sites, 4 recruiting
- Recruiting
Takeda Site 28
Beijing, Beijing Municipality, 100053
- Recruiting
Takeda Site 51
Changchun, Jilin, 130021
- Recruiting
Takeda Site 29
Guangzhou, Guangzhou, 510515
- Recruiting
Takeda Site 27
Shanghai, Shanghai Municipality, 200040
Italy3 sites, 3 recruiting
- Recruiting
Takeda Site 23
Bologna, 40139
- Recruiting
Takeda Site 22
Rome, Lazio, 133
- Recruiting
Takeda Site 31
Verona, Veneto, 37134
South Korea3 sites, 3 recruiting
- Recruiting
Takeda Site 16
Junggu, Daegu Gwang'yeogsi
- Recruiting
Takeda Site 21
Seoul, Seoul Teugbyeolsi, 3080
- Recruiting
Takeda Site 19
Suwon, Gyeonggido, 16247
France2 sites, 1 recruiting
- Withdrawn
Takeda Site 17
Montpellier, Hérault, 34090
- Recruiting
Takeda Site 15
Paris, 75013
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.
Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
- Conditions
- Narcolepsy Type 2
- Being tested
- TAK-360, Placebo
- Keywords
- Narcolepsy without Cataplexy, NT2, TAK-360
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-360Drug
TAK-360 tablet.
PlaceboOther
TAK-360 matching placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| TAK-360 | Experimental | Participants will receive TAK-360 tablets, orally, for 4 weeks. Receives: Drug: TAK-360 |
| Placebo | Placebo comparator | Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 15 Weeks
Secondary outcomes (2)
Change from Baseline at Week 4 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, Week 4
Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
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 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, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start6 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 2Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 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
- NCT06952699
- Sponsor's protocol ID
- TAK-360-2001
- Other IDs
- 2024-517711-70-01
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2025
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
- ClinicalTrials.gov ID
- NCT06952699
- Acronym / sponsor ID
- TAK-360-2001
- Conditions
- Narcolepsy Type 2
- Keywords
- Narcolepsy without Cataplexy, NT2, TAK-360
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 May 2025 (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.
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.
Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-360 | Experimental | Drug: TAK-360Participants will receive TAK-360 tablets, orally, for 4 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].
- The participant has a documented, current diagnosis of NT2.
Key exclusion criteria (7 listed)
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
- The participant has medically significant thyroid disease.
- The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
- The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
- The participant has a clinically significant history of head injury or head trauma.
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-360TAK-360 tablet. | Drug | TAK-360 |
| PlaceboTAK-360 matching placebo tablet. | Other | Placebo |
Primary outcome
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to 15 Weeks
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.
2 secondary outcomes
Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
Time frame: Baseline, Week 4
Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
Time frame: Baseline, Week 4
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 8 Oct 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.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 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-360 in people with Narcolepsy Type 2, run by Takeda at 52 sites in 7 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 2 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: looking for participants now, as of the sponsor's last update on 8 Oct 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, Japan, China, Italy, South Korea and 2 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?
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 Treatment-emergent Adverse Event (TEAE) (time frame: Up to 15 Weeks). 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 8 Oct 2026.