Excessive Daytime Sleepiness Clinical Trials

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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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Japan
Takeda Site 1
RECRUITING
Kumamoto
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2026-06-04
Estimated Completion Date: 2027-11-28
Participants
Target number of participants: 92
Treatments
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.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov