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New treatment option for Narcolepsy Type 1
Official title A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
ClinicalTrials.gov ID: NCT07633301
What this study is testing
What is TAK-360?
TAK-360 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for narcolepsy type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1. Key
You likely can't join if
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease...
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except 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...
- The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without...
See the full eligibility criteria
- The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1. Key
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except 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.
- The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be...
- The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
- The participant plans to participate in any other treatment trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004.
- The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- Miami, Florida, United States
- Cincinnati, Ohio, United States
- Macquarie Park, New South Wales, Australia
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Herault, Montpelier, France
- Paris, France
- Bologna, Emilia-Romagna, Italy
- Verona, Veneto, Italy
- Fukuoka, Fukuoka, Japan
- Kumamoto, Kumamoto, Japan
- Isahaya-shi, Nagasaki, Japan
- Yodogawa-ku, Osaka-shi, Osaka, Japan
- Shinjuku-ku, Tokyo, Japan
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; Miami, Florida, United States; Cincinnati, Ohio, United States; Macquarie Park, New South Wales, Australia; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.