Narcolepsy Type 1Phase 2NCT07633301
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
A Phase 2 study testing TAK-360 in people with Narcolepsy Type 1, run by Takeda at 18 sites in 7 countries.
Trial summary
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narcolepsy Type 1
- 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
- 92 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 4 Jun 2026to 28 Nov 2027
- 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 has a body mass index within the range 18 to 40 kilograms per meter square (kg/m^2) (inclusive).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.
Who cannot join
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except 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.
- 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 carcinoma; these participants may be included after approval by the medical monitor).
Show all 9Show fewer
- The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
- The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004.
- The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
Trial locations and contacts
18 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 7 countries
Japan5 sites, 5 recruiting
- Recruiting
Takeda Site 17
Fukuoka, Fukuoka, 812-0025
- Recruiting
Takeda Site 18
Isahaya-shi, Nagasaki, 854-0081
- Recruiting
Takeda Site 1
Kumamoto, Kumamoto, 862-0954
- Recruiting
Takeda Site 16
Shinjuku-ku, Tokyo, 162-0851
- Not yet recruiting
Takeda Site 15
Yodogawa-ku, Osaka-shi, Osaka, 532-0003
United States3 sites, 3 recruiting
- Recruiting
Takeda Site 13
Cincinnati, Ohio, 45245
- Recruiting
Takeda Site 14
Miami, Florida, 33176
- Not yet recruiting
Takeda Site 12
Redwood City, California, 94063
China3 sites, 3 recruiting
- Recruiting
Takeda Site 4
Beijing, Beijing Municipality, 100053
- Recruiting
Takeda Site 3
Guangzhou, Guangdong, 510515
- Recruiting
Takeda Site 5
Zhengzhou, Henan, 450003
France2 sites, 2 recruiting
- Not yet recruiting
Takeda Site 6
Herault, Montpelier, 34000
- Not yet recruiting
Takeda Site 7
Paris, 75013
Italy2 sites, 2 recruiting
- Not yet recruiting
Takeda Site 8
Bologna, Emilia-Romagna, 40139
- Not yet recruiting
Takeda Site 9
Verona, Veneto, 37134
Spain2 sites, 2 recruiting
- Not yet recruiting
Takeda Site 11
Barcelona, 8036
- Not yet recruiting
Takeda Site 10
Madrid, 28043
Australia1 site, 1 recruiting
- Not yet recruiting
Takeda Site 2
Macquarie Park, New South Wales, 2113
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.
The participants will have to visit the clinic multiple times during this study.
- Conditions
- Narcolepsy Type 1
- Being tested
- TAK-360, Placebo
- Keywords
- Drug Therapy, Narcolepsy With Cataplexy, NT1
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-360Drug
TAK-360 tablet
PlaceboDrug
TAK-360 matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A: TAK-360 | Experimental | Participants will receive TAK-360 tablets, orally. Receives: Drug: TAK-360 |
| Part A: Placebo | Placebo comparator | Participants will receive TAK-360 matching placebo tablets, orally. Receives: Drug: Placebo |
| Part B: TAK-360 | Experimental | Participants will receive TAK-360 tablets, orally. Receives: Drug: TAK-360 |
| Part B: Placebo | Placebo comparator | Participants will receive TAK-360 matching placebo tablets, orally. Receives: Drug: Placebo |
| Part C | Experimental | Participants will receive TAK-360 tablets, orally. Receives: Drug: TAK-360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. 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 approximately 28 weeks
Secondary outcomes (3)
Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
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.
Measured: Baseline, Week 6
Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
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 reference range.
Measured: Baseline, Week 6
Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start4 Jun 2026
- Primary completion28 Nov 2027 (estimated)
- Study completion28 Nov 2027 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 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
- NCT07633301
- Sponsor's protocol ID
- TAK-360-2004
- Other IDs
- 2025-522587-33-00, jRCT2031260186, 2025
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 29 Jun 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
- ClinicalTrials.gov ID
- NCT07633301
- Acronym / sponsor ID
- TAK-360-2004
- Conditions
- Narcolepsy Type 1
- Keywords
- Drug Therapy, Narcolepsy With Cataplexy, NT1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 28 Nov 2027 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 8 Jun 2026 (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 is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.
The participants will have to visit the clinic multiple times during this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: TAK-360 | Experimental | Drug: TAK-360Participants will receive TAK-360 tablets, orally. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive TAK-360 matching placebo tablets, orally. |
| Part B: TAK-360 | Experimental | Drug: TAK-360Participants will receive TAK-360 tablets, orally. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive TAK-360 matching placebo tablets, orally. |
| Part C | Experimental | Drug: TAK-360Participants will receive TAK-360 tablets, orally. |
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 has a body mass index within the range 18 to 40 kilograms per meter square (kg/m^2) (inclusive).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.
Key exclusion criteria (9 listed)
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except 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.
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 | Part A: TAK-360, Part B: TAK-360, Part C |
| PlaceboTAK-360 matching placebo tablet | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 28 weeks
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. 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.
3 secondary outcomes
Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
Time frame: Baseline, Week 6
Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
Time frame: Baseline, Week 6
Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6
Time frame: Week 6
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 29 Jun 2026.
- 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.
- 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.
- 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
18 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 1, run by Takeda at 18 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 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan, United States, China, France, Italy 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?
Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 28 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 29 Jun 2026.