NCT07633301 A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
| NCT ID | NCT07633301 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Takeda |
| Condition | Narcolepsy Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2027-11-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2026-06-04 with a primary completion date of 2027-11-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Key Inclusion Criteria: 1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1. Key Exclusion Criteria: 1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness. 2. 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. 3. The participant has a clinically significant history of head injury or head trauma. 4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood). 5. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation. 6. 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). 7. 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. 8. 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. 9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
Contact & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT07633301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Narcolepsy Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07633301 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07633301 currently recruiting?
Yes, NCT07633301 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT07633301 trial being conducted?
This trial is being conducted at Redwood City, United States, Miami, United States, Cincinnati, United States, Macquarie Park, Australia and 11 additional locations.
Who is sponsoring the NCT07633301 clinical trial?
NCT07633301 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 92 participants.