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

NCT05458193 | Completed Phase 1

• 2 other identifiers: ID-078-1212022-000098-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Treatment difference (daridorexant - placebo) for apnea/hypopnea index

  The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by polysomnography. Polysomnography recording will start at the time of "lights off" and last for 8 hours. The apnea/hypopnea index is defined by the total number of apneas (pause in respiration ≥ 10 sec) plus hypopneas (peak signal excursions drop by ≥ 30% of pre-event baseline for at least 10 sec accompanied by a decrease of SpO2 ≥ 3% from pre-event baseline and/or the event is associated with an arousal) during total sleep time (TST), divided by TST (in min), then multiplied by 60.

  Night 5 of period 1 and period 2 (Total duration: 2 days)

Secondary Outcomes (4)

• Treatment difference (daridorexant - placebo) in mean peripheral oxygen saturation (SpO2) during total sleep time

  Night 5 of period 1 and period 2 (Total duration: 2 days)

• Treatment difference (daridorexant - placebo) for total sleep time

  Night 5 of period 1 and period 2 (Total duration: 2 days)

• Daridorexant plasma concentration

  9 hours post-dose on Day 2 and Day 6 (Total duration: up to 2 days)

• Incidence of treatment-emergent adverse events

  Day 1 up to Day 13 (Total duration: 13 days)

Study Arms (2)

Daridorexant

EXPERIMENTAL

50 mg once daily from Day 1 to Day 5

Drug: Daridorexant

Placebo

PLACEBO COMPARATOR

Matching placebo once daily from Day 1 to Day 5

Drug: Placebo

Interventions

Daridorexant DRUG

Film-coated tablet for oral use

Also known as: ACT-541468

Daridorexant

Placebo DRUG

Film-coated tablet for oral use

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

ASR Advanced Sleep Research GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

daridorexant

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-way cross-over

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: August 17, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)