Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder (NCT NCT03545191)
NCT ID: NCT03545191
Last Updated: 2022-03-25
Results Overview
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
930 participants
Primary outcome timeframe
From baseline to Month 1 (i.e. for up to 1 month)
Results posted on
2022-03-25
Participant Flow
Participant milestones
| Measure |
Daridorexant 25 mg
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Overall Study
STARTED
|
310
|
310
|
310
|
|
Overall Study
COMPLETED
|
288
|
285
|
280
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
30
|
Reasons for withdrawal
| Measure |
Daridorexant 25 mg
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
2
|
7
|
|
Overall Study
Other reasons
|
3
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Baseline characteristics by cohort
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
Total
n=930 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
189 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
566 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
121 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
364 Participants
n=4 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
624 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
259 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
783 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
287 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
839 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Month 1 (i.e. for up to 1 month)"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
|
-18.40 minutes
Interval -22.126 to -14.674
|
-28.98 minutes
Interval -32.668 to -25.299
|
-6.20 minutes
Interval -9.928 to -2.475
|
PRIMARY outcome
Timeframe: From baseline to Month 3 (i.e. for up to 3 months)"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
|
-22.97 minutes
Interval -26.955 to -18.988
|
-29.41 minutes
Interval -33.399 to -25.427
|
-11.11 minutes
Interval -15.131 to -7.088
|
PRIMARY outcome
Timeframe: From baseline to Month 1 (i.e. for up to 1 month)"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
|
-28.17 minutes
Interval -31.509 to -24.827
|
-31.20 minutes
Interval -34.506 to -27.896
|
-19.85 minutes
Interval -23.177 to -16.515
|
PRIMARY outcome
Timeframe: From baseline to Month 3 (i.e. for up to 3 months)"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
|
-30.73 minutes
Interval -34.037 to -27.417
|
-34.80 minutes
Interval -38.118 to -31.49
|
-23.13 minutes
Interval -26.464 to -19.803
|
SECONDARY outcome
Timeframe: From baseline to Month 1 (i.e. for up to 1 month)"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
|
34.18 minutes
Interval 28.718 to 39.645
|
43.62 minutes
Interval 38.173 to 49.063
|
21.56 minutes
Interval 16.101 to 27.022
|
SECONDARY outcome
Timeframe: From baseline to Month 3 (i.e. for up to 3 months)"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
|
47.83 minutes
Interval 41.333 to 54.328
|
57.67 minutes
Interval 51.171 to 64.168
|
37.90 minutes
Interval 31.393 to 44.404
|
SECONDARY outcome
Timeframe: From baseline to Month 1 (i.e. for up to 1 month)The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
|
-2.77 Scores on a scale
Interval -3.316 to -2.225
|
-3.77 Scores on a scale
Interval -4.309 to -3.224
|
-2.02 Scores on a scale
Interval -2.566 to -1.476
|
SECONDARY outcome
Timeframe: From baseline to Month 3 (i.e. for up to 3 months)The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
|
-4.78 Scores on a scale
Interval -5.491 to -4.067
|
-5.70 Scores on a scale
Interval -6.405 to -4.987
|
-3.79 Scores on a scale
Interval -4.503 to -3.08
|
POST_HOC outcome
Timeframe: From baseline to Month 1 (i.e. for up to 1 month)Post-hoc analyses were performed using log-transformed LPS data, as the LPS values at baseline more closely resembled a log-normal distribution (skewed to the right) than a normal distribution.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 1 in Log-transformed LPS (LSGM Ratio to Baseline)
|
0.49 minutes
Interval 0.45 to 0.54
|
0.45 minutes
Interval 0.41 to 0.49
|
0.62 minutes
Interval 0.57 to 0.67
|
POST_HOC outcome
Timeframe: From baseline to Month 3 (i.e. for up to 3 month)Post-hoc analyses were performed using log-transformed LPS data, as the LPS values at baseline more closely resembled a log-normal distribution (skewed to the right) than a normal distribution.
Outcome measures
| Measure |
Daridorexant 25 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=310 Participants
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=310 Participants
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Change From Baseline to Month 3 in Log-transformed LPS (LSGM Ratio to Baseline)
|
0.43 minutes
Interval 0.4 to 0.48
|
0.41 minutes
Interval 0.37 to 0.45
|
0.56 minutes
Interval 0.51 to 0.61
|
Adverse Events
Daridorexant 25 mg
Serious events: 2 serious events
Other events: 44 other events
Deaths: 1 deaths
Daridorexant 50 mg
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daridorexant 25 mg
n=310 participants at risk
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=308 participants at risk
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=309 participants at risk
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/309 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/309 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/309 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/309 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Cardiac disorders
Cardiac arrest
|
0.32%
1/310 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/309 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.65%
2/309 • Number of events 2 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
General disorders
Influenza like illness
|
0.32%
1/310 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/309 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.65%
2/309 • Number of events 2 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/309 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/309 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/309 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/310 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.00%
0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
0.32%
1/309 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
Other adverse events
| Measure |
Daridorexant 25 mg
n=310 participants at risk
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Daridorexant 50 mg
n=308 participants at risk
Daridorexant was administered as tablets, orally, once daily in the evening.
|
Placebo
n=309 participants at risk
Matching placebo was administered as tablets, orally, once daily in the evening.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.5%
17/310 • Number of events 24 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
6.5%
20/308 • Number of events 27 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
3.9%
12/309 • Number of events 18 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
28/310 • Number of events 28 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
7.8%
24/308 • Number of events 26 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
7.8%
24/309 • Number of events 29 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
The number of subjects affected is the number of subjects with at least one event.
|
Additional Information
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Results disclosure agreements
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Restriction type: OTHER