A Study of the Effect of Daridorexant on Nighttime Body P... | NCT05702177

ID	Type	Description	Link
2022-002922-28	EudraCT Number
NL83038.056.22	Other Identifier	CCMO

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Daridorexant 25 mg	Experimental	Subjects will receive a daridorexant 25 mg tablet for oral administration.	Drug: Daridorexant 25 mg
Daridorexant 50 mg	Experimental	Subjects will receive a daridorexant 50 mg tablet for oral administration.	Drug: Daridorexant 50 mg
Placebo	Placebo Comparator	Subjects will receive a daridorexant-matching placebo tablet for oral administration.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Daridorexant 25 mg	Drug	A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.	Daridorexant 25 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment difference in postural stability (daridorexant and placebo)	Postural stability in the MOTN (at 4 h post-dose) evaluated by body sway. Body sway will be assessed approximately 5 min after awakening, with the subject standing comfortably, with eyes closed, using a body sway meter (string attached to the waist). Body movements over 2 min are integrated and expressed as mm sway.	Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.

Secondary Outcomes

Measure	Description	Time Frame
Treatment difference in auditory awakening threshold (daridorexant and placebo)	The auditory awakening threshold will be assessed at 4 h post dose by applying a 1000 Hz tone, starting at a noise level of 35 dB, increasing in steps of 5 dB until either the subject is awake, or the maximum noise level (100 dB) is reached. The tone will be delivered via a calibrated loudspeaker for 3 s with a 15 s interval between the different noise levels. The subjects must confirm awakening by verbally saying "I'm awake" or similar response, e.g., waving a hand. If a subject does not respond after receiving the initial 100 dB tone, additional 100 dB stimuli will be applied in 15 s intervals for up to 2 min. The outcome measure is the noise level (dB) at which subjects indicate that they are awake. If a subject remains asleep, he/she will be physically awakened by a technician. If a subject will not awaken to any of the tones presented, the maximum 100 dB tone will be recorded as the auditory awakening threshold.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
Male and female subjects aged 18 years or older at Screening (18 subjects must be 65 years or older).
Woman of childbearing potential (WoCBP) who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose. She must agree to use consistently and correctly (from Screening, during the entire study, and for at least 5-7 days after last study treatment administration) an acceptable method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated 1 month before first treatment administration.
Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone [FSH] test), with previous bilateral salpingectomy, bilateral-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.

Exclusion Criteria:

Known hypersensitivity to daridorexant, or treatments of the same class, or any of its excipients.
Any known factor or disease (e.g., unstable medical condition, significant medical disorder, or acute illness) that might interfere with subject's safety, study conduct, or interpretation of the results, such as
- History of narcolepsy.
- Shift work within 2 weeks prior to Screening, or planned shift work during the study.
- Travel across 3 or more time zones within 1 week prior to Screening, or planned travel across 3 or more time zones during the study.
Previous (i.e., within 2 weeks prior to first study treatment administration) and ongoing treatment with any prescribed central nervous system (CNS)-active medications, and/or diuretics that would affect nighttime rest, and/or moderate to strong cytochromes P450(CYP)3A4 inhibitors or inducers.