Clinical trial NCT06952699: A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Narcolepsy Type 2
Keywords: Narcolepsy without Cataplexy
NT2
TAK-360
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
2. The participant has a documented, current diagnosis of NT2.

Key Exclusion Criteria:

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
2. The participant has medically significant thyroid disease.
3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Primary outcomes:
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to 15 Weeks
Secondary outcomes:
measure: Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score
timeFrame: Baseline, Week 4
measure: Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Takeda Site 14
state: California
city: Santa Ana
country: United States
facility: Takeda Site 10
state: California
city: Colorado Springs
country: United States
facility: Takeda Site 1
state: Colorado
city: Brandon
country: United States
facility: Takeda Site 13
state: Florida
city: Orlando
country: United States
facility: Takeda Site 3
state: Florida
city: Saint Louis
country: United States
facility: Takeda Site 4
state: Missouri
city: Denver
country: United States
facility: Takeda Site 8
state: North Carolina
city: Huntersville
country: United States
facility: Takeda Site 6
state: North Carolina
city: Cincinnati
country: United States
facility: Takeda Site 5
state: Ohio
city: Columbia
country: United States
facility: Takeda Site 2
state: South Carolina
city: San Antonio
country: United States
facility: Takeda Site 7
state: Texas
city: Norfolk
country: United States
facility: Takeda Site 11
state: Virginia
city: Beijing
country: China
facility: Takeda Site 28
state: Beijing
city: Guangzhou
country: China
facility: Takeda Site 29
state: Guangzhou
city: Shanghai
country: China
facility: Takeda Site 27
state: Shanghai
city: Montpellier
country: France
facility: Takeda Site 17
city: Paris
country: France
facility: Takeda Site 15
city: New Territories
country: Hong Kong
facility: Takeda Site 25
city: Roma
country: Italy
facility: Takeda Site 22
state: Lazio
city: Bellaria
country: Italy
facility: Takeda Site 23
state: Verona
city: Yokohama
country: Japan
facility: Takeda Site 24
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Takeda Site 9
state: Kumamoto
city: Urasoe
country: Japan
facility: Takeda Site 30
state: Okinawa
city: Bunkyo-ku
country: Japan
facility: Takeda Site 20
state: Tokyo
city: Sumida-Ku
country: Japan
facility: Takeda Site 26
state: Tokyo
city: Osaka-Shi
country: Japan
facility: Takeda Site 12
state: Ôsaka
city: Jung-Gu
country: Korea, Republic of
facility: Takeda Site 16
state: Daegu Gwang'yeogsi
city: Suwon
country: Korea, Republic of
facility: Takeda Site 19
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Takeda Site 21
state: Seoul Teugbyeolsi
city: Madrid
country: Spain
facility: Takeda Site 18
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: