A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)

Part of paid clinical trials in Redwood City, California.

Sponsor
Takeda
Study ID
NCT07633301
Phase
PHASE2
Status
Recruiting
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Conditions

  • Narcolepsy Type 1

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TAK-360 — DRUG
    TAK-360 tablet
  • Placebo — DRUG
    TAK-360 matching placebo tablet

Study Details

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.

Key Dates

Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
Nov 28, 2027
Completion
Nov 28, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
Takeda Site 12Redwood CityCalifornia94063-
Takeda Site 14MiamiFlorida33176-
Takeda Site 13CincinnatiOhio45245-

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