A Study of TAK-861 in Participants With Narcolepsy Type 2

Completed · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy Type 2

In brief

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Key facts

Study ID

NCT05687916

Run by

Takeda

People needed

71

Starts

2023-01-09

Expected to finish

2023-12-25

Last updated by the study team

2025-01-09

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
• Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
• The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.
• Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.

You may not qualify if…

• The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
• The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
• The participant has one or more of the following psychiatric disorders:
• Any current unstable psychiatric disorder.
• Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
• Current diagnosis or history of substance use disorder as defined in the DSM-5. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
• Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
• The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
• The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

Where it is running

• Mayo Clinic Arizona-PPDS — Scottsdale, Arizona, United States
• Stanford Center for Sleep Sciences and Medicine — Redwood City, California, United States
• SDS Clinical Trials, Inc. — Santa Ana, California, United States
• Delta Waves LLC - Hunt - PPDS — Colorado Springs, Colorado, United States
• Florida Pediatric Research Institute — Orlando, Florida, United States
• Neurotrials Research — Atlanta, Georgia, United States
• Georgia Neuro Center — Gainesville, Georgia, United States
• Neurocare Inc. — Newton, Massachusetts, United States
• Henry Ford Medical Center - Columbus — Novi, Michigan, United States
• St. Lukes Sleep Medicine and Research Center — Chesterfield, Missouri, United States
• Research Carolina Elite — Denver, North Carolina, United States
• ARSM Research, LLC — Huntersville, North Carolina, United States
• Tricoastal Narcolepsy and Sleep Disorders Center, PLLC — Cincinnati, Ohio, United States
• Intrepid Research — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio Sleep Medicine Institute — Dublin, Ohio, United States
• Medical University of South Carolina - PPDS — Charleston, South Carolina, United States
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States
• Comprehensive Sleep Medicine Associates - Sugar Land — Houston, Texas, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States
• Children's Specialty Group — Norfolk, Virginia, United States
• Woolcock Institute of Medical Research — Glebe, New South Wales, Australia
• Terveystalo Helsinki Sleep Clinic — Helsinki, Uusimaa, Finland
• Hopital Saint-Eloi — Montpellier, Herault, France
• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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