Trial Outcomes & Findings for A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia (NCT NCT05597020)

Last Updated: 2025-04-18

Results Overview

Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

From baseline to Week 4 per treatment period.

Results posted on

2025-04-18

Participant Flow

16 sites in 3 countries (USA, Spain and Germany) screened 149 subjects, and 9 sites enrolled (i.e., randomized) at least one subject. Screening started on 18 January 2023 (first subject first visit) and the first subject was enrolled on 16 February 2023.

This study included a screening period of 14-21 days. Subjects who met the inclusion criteria and none of the exclusion criteria were eligible to be enrolled in the study and randomized to one of the two treatment sequences.

Participant milestones

Participant milestones
Measure	Daridorexant 50 mg, Then Placebo Subjects first received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days. After a washout period of 14 to 21 days, they then received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days.	Placebo, Then Daridorexant 50 mg Subjects first received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days. After a washout period of 14 to 21 days, they then received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days.
Treatment Period I STARTED	30	30
Treatment Period I COMPLETED	30	30
Treatment Period I NOT COMPLETED	0	0
Washout STARTED	30	30
Washout COMPLETED	28	30
Washout NOT COMPLETED	2	0
Treatment Period II STARTED	28	30
Treatment Period II COMPLETED	26	29
Treatment Period II NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Daridorexant 50 mg, Then Placebo Subjects first received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days. After a washout period of 14 to 21 days, they then received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days.	Placebo, Then Daridorexant 50 mg Subjects first received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days. After a washout period of 14 to 21 days, they then received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days.
Washout Forbidden medication	2	0
Treatment Period II Advice from primary care physician	1	0
Treatment Period II Subject lost investigational product	1	0
Treatment Period II Private reasons	0	1

Baseline Characteristics

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daridorexant 50 mg, Then Placebo n=30 Participants Subjects first received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days. After a washout period of 14 to 21 days, they then received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days.	Placebo, Then Daridorexant 50 mg n=30 Participants Subjects first received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days. After a washout period of 14 to 21 days, they then received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days.	Total n=60 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Germany	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Spain	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Subjective total sleep time (sTST)	367.20 minutes STANDARD_DEVIATION 58.60 • n=5 Participants	353.17 minutes STANDARD_DEVIATION 54.85 • n=7 Participants	360.31 minutes STANDARD_DEVIATION 56.72 • n=5 Participants
Number of nocturnal voids	3.74 Number of nocturnal voids STANDARD_DEVIATION 1.05 • n=5 Participants	3.52 Number of nocturnal voids STANDARD_DEVIATION 0.89 • n=7 Participants	3.63 Number of nocturnal voids STANDARD_DEVIATION 0.97 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to Week 4 per treatment period.

Population: The analysis included all randomized subjects who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Daridorexant 50 mg n=60 Participants Subjects received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days, in either crossover treatment period.	Placebo n=60 Participants Subjects received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days, in either crossover treatment period.
Change From Baseline to Week 4 in sTST	56.6 minutes Interval 46.0 to 67.2	35.7 minutes Interval 25.0 to 46.4

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to Week 4 per treatment period.

Population: The analysis included all randomized subjects who received at least one dose of study treatment.

The number of nocturnal voids is the total of all nocturnal voids reported by the subject in the voiding diary. Baseline is the mean value based on subject's voiding diary entries for number of nocturnal voids across 3 nights during the screening period. Week 4 is the mean value based on subject's voiding diary entries for number of nocturnal voids across the 3 nights immediately preceding the Week 4 visit of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).

Outcome measures

Outcome measures
Measure	Daridorexant 50 mg n=60 Participants Subjects received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days, in either crossover treatment period.	Placebo n=60 Participants Subjects received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days, in either crossover treatment period.
Change From Baseline to Week 4 in Number of Nocturnal Voids Assessed Using a Voiding Diary	-1.6 number of nocturnal voids Standard Deviation 1.4	-1.3 number of nocturnal voids Standard Deviation 1.3

Adverse Events

Daridorexant 50 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Daridorexant 50 mg n=60 participants at risk Subjects received a daridorexant 50 mg film-coated tablet once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days, in either crossover treatment period.	Placebo n=58 participants at risk Subjects received a placebo film-coated tablet (matching daridorexant 50 mg) once daily in the evening within approximately 30 min before going to bed, for 29 (± 2) days, in either crossover treatment period.
Gastrointestinal disorders Dry mouth	5.0% 3/60 • Number of events 3 • Treatment-emergent adverse events from the 29-day (± 2 days) treatment periods are reported. Adverse events were considered treatment-emergent if the date of onset or worsening was from the first intake of study treatment up to 5 days after the end of study treatment.	3.4% 2/58 • Number of events 2 • Treatment-emergent adverse events from the 29-day (± 2 days) treatment periods are reported. Adverse events were considered treatment-emergent if the date of onset or worsening was from the first intake of study treatment up to 5 days after the end of study treatment.
General disorders Fatigue	5.0% 3/60 • Number of events 3 • Treatment-emergent adverse events from the 29-day (± 2 days) treatment periods are reported. Adverse events were considered treatment-emergent if the date of onset or worsening was from the first intake of study treatment up to 5 days after the end of study treatment.	0.00% 0/58 • Treatment-emergent adverse events from the 29-day (± 2 days) treatment periods are reported. Adverse events were considered treatment-emergent if the date of onset or worsening was from the first intake of study treatment up to 5 days after the end of study treatment.

Additional Information

Idorsia Clinical Trial Information

Idorsia Pharmaceuticals Ltd

Phone: +1 856 661 3721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to the sponsor for review at least 60 days prior to submission for publication or presentation at a congress. Upon review, the sponsor may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator is permitted to write a publication during such a review period.
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