A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Not provided0 sites92 target enrollmentStarted: TBD

Conditions

Trial Snapshot

No summary available.

•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.

•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
•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 interventional trial while participating in TAK-360-
•The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.

Sponsor

Not provided