A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAK-360, Placebo.
- Who it may be relevant to
- Registry conditions: Narcolepsy Type 2. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, France, Italy, Japan +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug TAK-360
TAK-360 tablet. - Other Placebo
TAK-360 matching placebo tablet.
Primary outcome measures
- Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [Time frame: Up to 15 Weeks]
Secondary outcome measures (2)
- Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score [Time frame: Baseline, Week 4]
- Change from Baseline at Week 4 in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) [Time frame: Baseline, Week 4]
Eligibility criteria
Inclusion criteria
- 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) \[inclusive\].
- The participant has a documented, current diagnosis of NT2.
Exclusion criteria
- The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
- The participant has medically significant thyroid disease.
- 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).
- 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).
- The participant has a clinically significant history of head injury or head trauma.
- The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 31 centers
- Takeda Site 36 — Auburn
- Takeda Site 39 — Chandler
- Takeda Site 40 — Chula Vista
- Takeda Site 14 — Redwood City
- Takeda Site 10 — Santa Ana
- Takeda Site 1 — Colorado Springs
- Takeda Site 48 — Bradenton
- Takeda Site 13 — Brandon
- … and 23 more centers
Japan · 8 centers
- Takeda Site 24 — Kohoku-ku, Yokohama-Shi
- Takeda Site 9 — Kumamoto
- Takeda Site 53 — Isahaya-shi
- Takeda Site 30 — Urasoe-Shi
- Takeda Site 20 — Shinjuku-ku
- Takeda Site 26 — Sumida-Ku
- Takeda Site 52 — Fukuoka
- Takeda Site 12 — Yodogawa-ku, Osaka-shi
China · 4 centers
- Takeda Site 28 — Beijing
- Takeda Site 29 — Guangzhou
- Takeda Site 51 — Changchun
- Takeda Site 27 — Shanghai
Italy · 3 centers
- Takeda Site 22 — Rome
- Takeda Site 31 — Verona
- Takeda Site 23 — Bologna
South Korea · 3 centers
- Takeda Site 16 — Junggu
- Takeda Site 19 — Suwon
- Takeda Site 21 — Seoul
France · 2 centers
- Takeda Site 17 — Montpellier
- Takeda Site 15 — Paris
Spain · 1 center
- Takeda Site 18 — Madrid
Identifiers
NCT: NCT06952699 · TAK-360-2001 · 2024-517711-70-01