RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-05-06
Study Completion:2026-04-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06952699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. The participant has a documented, current diagnosis of NT2.
  1. 1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
  2. 2. The participant has medically significant thyroid disease.
  3. 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. 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. 5. The participant has a clinically significant history of head injury or head trauma.
  6. 6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
  7. 7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Takeda Site 14
Redwood City, California, 94063-3132
United States
Takeda Site 10
Santa Ana, California, 92705-8519
United States
Takeda Site 1
Colorado Springs, Colorado, 80918-3408
United States
Takeda Site 13
Brandon, Florida, 33511-5719
United States
Takeda Site 3
Orlando, Florida, 32803-1468
United States
Takeda Site 4
Saint Louis, Missouri, 63123-6968
United States
Takeda Site 8
Denver, North Carolina, 28037
United States
Takeda Site 6
Huntersville, North Carolina, 28078-5082
United States
Takeda Site 5
Cincinnati, Ohio, 45245-4500
United States
Takeda Site 2
Columbia, South Carolina, 29201-2923
United States
Takeda Site 7
San Antonio, Texas, 78229-4849
United States
Takeda Site 11
Norfolk, Virginia, 23510-1021
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2026-04-23

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2026-04-23

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy without Cataplexy
  • NT2
  • TAK-360

Additional Relevant MeSH Terms

  • Narcolepsy Type 2