Recruiting
Phase 2

TAK-360

Sponsor:

Takeda

Code:

NCT07633301

Conditions

Narcolepsy Type 1

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

TAK-360

Placebo

Study Details

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.

Conditions

Narcolepsy Type 1

Study ID

NCT07633301

Start date

Jun 4, 2026

Status verified date

Jun, 2026

Completion date

Nov 28, 2027

Anticipated

Primary completion date

Nov 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: TAK-360

Participants will receive TAK-360 tablets, orally.

placebo comparator: Part A: Placebo

Participants will receive TAK-360 matching placebo tablets, orally.

experimental: Part B: TAK-360

Participants will receive TAK-360 tablets, orally.

placebo comparator: Part B: Placebo

Participants will receive TAK-360 matching placebo tablets, orally.

experimental: Part C

Participants will receive TAK-360 tablets, orally.

Interventions

TAK-360

TAK-360 tablet

Placebo

TAK-360 matching placebo tablet

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 ]

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327medinfoUS@takeda.com

Locations

Takeda Site 14

Recruiting

Miami, Florida, United States, 33176

Takeda Site 13

Recruiting

Cincinnati, Ohio, United States, 45245

More Information

Sponsor

Takeda

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Drug Therapy
  • Narcolepsy With Cataplexy
  • NT1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Takeda on 2026-06-29.