A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

NCT ID: NCT05458193

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2023-02-28

Brief Summary

A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).

Detailed Description

Each subject will participate in 2 study periods. Participants will receive 50 mg daridorexant in one period and placebo in the other period. Both periods will last from Day 1 (first administration) in the evening to Day 6 in the morning (defined as End-of-Period). The 2 periods will be separated by an in-between period of 1 to 2 weeks. An End-of-Study examination will take place 1 to 2 weeks after last administration of study treatment.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Daridorexant

50 mg once daily from Day 1 to Day 5

Group Type: EXPERIMENTAL

Daridorexant

Intervention Type: DRUG

Film-coated tablet for oral use

Placebo

Matching placebo once daily from Day 1 to Day 5

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Film-coated tablet for oral use

Interventions

Daridorexant

Film-coated tablet for oral use

Intervention Type: DRUG

Placebo

Film-coated tablet for oral use

Intervention Type: DRUG

Other Intervention Names

ACT-541468

Eligibility Criteria

Inclusion Criteria

• Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
• Male and female participants aged 18 years or older at Screening.
• Diagnosis of Obstructive Sleep Apnea (OSA) according to the International Classification of Sleep Disorders, documented by medical history and confirmed by a specialist.
• Severe intensity of OSA determined during OSA diagnosis and confirmed during both screening night polysomnography (PSG) and defined as apnea/hypopnea index greater than or equal to 30 events per hour.
• Patient who may require a continuous positive airway pressure (CPAP) device or a dental appliance device for the treatment of OSA must either not have started it or have withdrawn from it at least 2 months before randomization in this study. In all cases patients must not start using this type of device during the study.
• Women of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 and a negative urine pregnancy test on Day 1 pre-dose of the first study period. She must agree to consistently and correctly use a highly effective 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 at least 1 month before first treatment administration.
• Woman of non-childbearing potential, i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.

Exclusion Criteria

• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
• Legal incapacity or limited legal capacity or vulnerability (e.g., kept in detention) at Screening.
• Pregnant or lactating woman.
• Modified Swiss Narcolepsy Scale total score less than 0 at Screening or history of narcolepsy or cataplexy.
• Participant with clinically significant abnormality present on either or both screening night PSG.
• Evidence of any other clinically significant active pulmonary disease such as chronic obstructive pulmonary disease (as per Global Initiative for Obstructive Lung Disease), based on investigator's judgment.
• History of surgical intervention for OSA, except nose surgery.
• Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff from study site or the sponsor directly involved in the conduct of the study or their relatives.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

ASR Advanced Sleep Research GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

2022-000098-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-078-121

Identifier Type: -

Identifier Source: org_study_id