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

Part of paid clinical trials in Auburn, Alabama.

Sponsor
Takeda
Study ID
NCT06952699
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Narcolepsy Type 2

Eligibility Criteria

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

Interventions

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

Study Details

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Key Dates

Start date
May 6, 2025
Status verified
May 2026
Primary completion
Aug 20, 2026
Completion
Aug 20, 2026

Study Design

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

Arms

  • Experimental: TAK-360
    Participants will receive TAK-360 tablets, orally, for 4 weeks.
  • Placebo Comparator: Placebo
    Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.

Primary Outcome Measure

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 15 Weeks ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Takeda Site 36AuburnAlabama36832-
Takeda Site 39ChandlerArizona85224-
Takeda Site 40Chula VistaCalifornia91910-
Takeda Site 14Redwood CityCalifornia94063-3132-
Takeda Site 10Santa AnaCalifornia92705-8519-
Takeda Site 1Colorado SpringsColorado80918-3408-
Takeda Site 48BradentonFlorida34209-
Takeda Site 13BrandonFlorida33511-5719-
Takeda Site 46JacksonvilleFlorida32209-
Takeda Site 35MiamiFlorida33176-
Takeda Site 44MiamiFlorida33155-
Takeda Site 3OrlandoFlorida32803-1468-
Takeda Site 33OrlandoFlorida32807-
Takeda Site 32AtlantaGeorgia30328-
Takeda Site 49BowieMaryland20715-
Takeda Site 50LansingMichigan48911-
Takeda Site 34Lathrup VillageMichigan48076-
Takeda Site 4St LouisMissouri63123-6968-
Takeda Site 37MiddletownNew Jersey07748-
Takeda Site 8DenverNorth Carolina28037-
Takeda Site 6HuntersvilleNorth Carolina28078-5082-
Takeda Site 41Winston-SalemNorth Carolina27103-
Takeda Site 5CincinnatiOhio45245-4500-
Takeda Site 45ClevelandOhio44106-
Takeda Site 2ColumbiaSouth Carolina29201-2923-
Takeda Site 38AustinTexas78731-
Takeda Site 43DallasTexas75235-
Takeda Site 42El PasoTexas79912-
Takeda Site 47MansfieldTexas76063-
Takeda Site 7San AntonioTexas78229-4849-
Takeda Site 11NorfolkVirginia23510-1021-

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