What is TAK-360 studying for Narcolepsy Type 2?

TAK-360 is being studied to see how safe and tolerable it is for adults with Narcolepsy Type 2 and to find the right dose to help them stay awake. Researchers want to understand its effects compared to placebo to improve care for people with this condition.

Who may be eligible for this Narcolepsy Type 2 clinical trial?

Adults aged 18 to 70 with a confirmed diagnosis of Narcolepsy Type 2 may be eligible. Participants must meet weight and BMI requirements and not have other medical causes of daytime sleepiness or recent cancer history. Please review eligibility criteria for more details.

Is there any cost to participate in this Narcolepsy Type 2 clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 70Years

All Genders

ID06952699

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Adults With Narcolepsy Without Cataplexy NT2

Led by Takeda · Updated on 2026-05-27

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Narcolepsy Type 2 NT2 is a lifelong condition that causes excessive daytime sleepiness, sudden sleep episodes, and difficulty staying awake, affecting daily activities like driving and working. This trial is studying TAK-360, a medicine that acts like orexin, a brain chemical that helps keep people awake. The study aims to evaluate the safety, tolerability, and proper dosage of TAK-360 in adults with NT2. Participants will be randomly assigned to receive either TAK-360 or a placebo tablet orally for 4 weeks. The placebo looks like TAK-360 but contains no active medicine. This randomized, double-blinded trial compares TAK-360 with placebo to understand its effects on wakefulness and safety in adults with NT2. During the study, researchers will monitor side effects and measure sleepiness using tests like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at the start and after 4 weeks. Participants will be observed for up to 15 weeks to track any treatment-related adverse events. This trial helps determine how TAK-360 is tolerated and its impact on staying awake for adults with NT2.

CONDITIONS

Brief Title

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant weighs at least 40 kilograms
Body mass index (BMI) is between 16 and 38 kg/m² inclusive
Documented, current diagnosis of Narcolepsy Type 2 (NT2)
Age between 18 and 70 years

You will not qualify if you...

Current medical disorder causing excessive daytime sleepiness other than NT2
Medically significant thyroid disease
History of cancer within past 5 years, except treated and stable basal cell carcinoma or carcinoma in situ
Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody/antigen at screening
Clinically significant history of head injury or head trauma
History of epilepsy, seizure, or convulsion except a single febrile seizure in childhood
History of cerebral ischemia, transient ischemic attack within 5 years, intracranial aneurysm, or arteriovenous malformation

Research Team

Takeda Contact

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here