NIPH Clinical Trials Search

JRCT ID: jRCT2031230050

Registered date:22/04/2023

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedNarcolepsy Type 2
Date of first enrollment09/01/2023
Target sample size71
Countries of recruitmentUnited States,Japan
Study typeInterventional
Intervention(s)Experimental: TAK-861 Dose 1 or 2 TAK-861 dose 1 or 2, orally for 8 weeks. Placebo Comparator: Placebo TAK-861 matching placebo tablets, orally for 8 weeks.


Primary Outcome1.Change from Baseline to Week 8 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Time Frame: Baseline, Week 8 The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Secondary Outcome1.Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score Time Frame: Baseline, Week 8 The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. 2.Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) Time Frame: From baseline up to approximately 12 weeks An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Key inclusion & exclusion criteria

Age minimum>= 16age old
Age maximum<= 70age old
Include criteria1.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. 2.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.
Exclude criteria1.The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS. 2.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). 3.The participant has one or more of the following psychiatric disorders: a.Any current unstable psychiatric disorder. b.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). c.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.) d.Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months. 4.The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation. 5.The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

Related Information


Public contact
Name Contact for Clinical Trial Information
Address 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone +81-6-6204-2111
Affiliation Takeda Pharmaceutical Company Limited
Scientific contact
Name Hidenori Nonomura
Address 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone +81-6-6204-2111
Affiliation Takeda Pharmaceutical Company Limited