- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05458193
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of Daridorexant on Nighttime Respiratory Function and Sleep in Patients With Severe Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Idorsia Clinical Trials Information
- Phone Number: +41 58 844 19 77
- Email: idorsiaclinicaltrials@idorsia.com
Study Locations
-
-
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Berlin, Germany, 10117
- ASR Advanced Sleep Research GmBH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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pressure (CPAP) device or a dental appliance device for the treatment of OSA must either not have started it or have withdrawn from it at least 2 months before randomization in this study.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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daridorexant
50 mg once daily from Day 1 to Day 5
|
Film-coated tablet for oral use
Other Names:
|
Placebo Comparator: Placebo
Matching placebo once daily from Day 1 to Day 5
|
Film-coated tablet for oral use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment difference (daridorexant - placebo) for apnea/hypopnea index
Time Frame: Night 5 of period 1 and period 2 (Total duration: 2 days)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment difference (daridorexant - placebo) in mean peripheral oxygen saturation (SpO2) during total sleep time
Time Frame: Night 5 of period 1 and period 2 (Total duration: 2 days)
|
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by pulse oximetry. Pulse oximetry recording will start at the time of "lights off" and last for 8 hours. |
Night 5 of period 1 and period 2 (Total duration: 2 days)
|
Treatment difference (daridorexant - placebo) for total sleep time
Time Frame: Night 5 of period 1 and period 2 (Total duration: 2 days)
|
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. |
Night 5 of period 1 and period 2 (Total duration: 2 days)
|
Daridorexant plasma concentration
Time Frame: 9 hours post-dose on Day 2 and Day 6 (Total duration: up to 2 days)
|
9 hours post-dose on Day 2 and Day 6 (Total duration: up to 2 days)
|
|
Incidence of treatment-emergent adverse events
Time Frame: Day 1 up to Day 13 (Total duration: 13 days)
|
A treatment-emergent adverse event is any adverse event temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
|
Day 1 up to Day 13 (Total duration: 13 days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-078-121
- 2022-000098-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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