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

JRCT ID: jRCT2031230050

Registered date:22/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Narcolepsy Type 2
• Date of first enrollment: 09/01/2023
• Target sample size: 71
• Countries of recruitment: United States,Japan,Australia,Japan,Finland,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan
• Study type: Interventional

Intervention(s)

Placebo
Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.

TAK-861 2 milligrams (mg) BID
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

TAK-861 2 mg and 5 mg
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

Outcome(s)

Primary Outcome

1.Change from Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
Time Frame: Baseline, Week 8
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.

Secondary Outcome

1.Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8
Time Frame: Baseline, Week 8
The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. 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. The MMRM was used for analysis.

2.Number of Participants with at Least one Treatment Emergent Adverse Event (TEAE)
Time Frame: From first dose of the study drug up to end of the study (up to 3 months)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1.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 criteria

1.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

• Primary Sponsor: Nonomura Hidenori
• Secondary ID(s): NCT05687916,2022-002966-34,U1111-1277-4261