Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02839200
Collaborator
(none)
360
35
6
8.5
10.3
1.2
Study Details
Study Description
Brief Summary
This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Actual Study Start Date
:
Oct 4, 2016
Actual Primary Completion Date
:
Apr 12, 2017
Actual Study Completion Date
:
Jun 20, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ACT-541468 5 mg Each subject receives one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks |
Drug: ACT-541468 5 mg
Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
|
| Experimental: ACT-541468 10 mg Each subject receives one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks |
Drug: ACT-541468 10 mg
Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
|
| Experimental: ACT-541468 25 mg Each subject receives one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks |
Drug: ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
|
| Experimental: ACT-541468 50 mg Each subject receives two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks |
Drug: ACT-541468 25 mg
Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
| Active Comparator: Zolpidem Each subject receives one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks |
Drug: Zolpidem
Over-encapsulated zolpidem tablet at a strength of 10 mg
Drug: Placebo 2
Placebo capsules matching over-encapsulated zolpidem
|
| Placebo Comparator: Placebo Each subject receives two placebo capsules, once daily in the evening for 4 weeks |
Drug: Placebo 1
Placebo capsules matching ACT-541468 capsules
|
Outcome Measures
Primary Outcome Measures
- Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 [Baseline and Days 1&2]
WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Secondary Outcome Measures
- Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 [Baseline and Days 1&2]
LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
- Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4 [Baseline and Week 4]
sLSO is the self-reported time to fall asleep, as reported in the sleep diary
- Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4 [Baseline and Week 4]
sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Principal inclusion Criteria:
-
Signed informed consent prior to any study-mandated procedure.
-
Male or female aged 18-64 years (inclusive).
-
Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
-
Body mass index (BMI): 18.5 ≤ BMI (kg/m2) < 32.0.
-
Insomnia disorder according to DSM-5 criteria.
-
Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
-
Insomnia Severity Index score ≥ 15.
Principal exclusion Criteria:
-
Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
-
Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
-
Caffeine consumption ≥ 600 mg per day.
-
Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
-
Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel > or= 3 time zones during study.
-
Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
-
AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN (except known history of Gilbert's syndrome).
-
Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
-
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
-
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigator Site | Santa Monica | California | United States | 90404 |
| 2 | Investigator Site | Upland | California | United States | 91786 |
| 3 | Investigator Site | Brandon | Florida | United States | 33511 |
| 4 | Investigator Site | Clearwater | Florida | United States | 33765 |
| 5 | Investigator Site | Coral Gables | Florida | United States | 33134 |
| 6 | Investigator Site | DeLand | Florida | United States | 32720 |
| 7 | Investigator Site | Hollywood | Florida | United States | 33024 |
| 8 | Investigator Site | Miami | Florida | United States | 33143 |
| 9 | Investigator Site | Atlanta | Georgia | United States | 30342 |
| 10 | Investigator Site | Chicago | Illinois | United States | 60634 |
| 11 | Investigator Site | Indianapolis | Indiana | United States | 46250 |
| 12 | Investigator Site | Novi | Michigan | United States | 48377 |
| 13 | Investigator Site | Las Vegas | Nevada | United States | 89104 |
| 14 | Investigator Site | New York | New York | United States | 10019 |
| 15 | Investigator Site | Cincinnati | Ohio | United States | 45255 |
| 16 | Investigator Site | Berlin | Germany | 10115 | |
| 17 | Investigator Site | Berlin | Germany | 10117 | |
| 18 | Investigator Site | Berlin | Germany | 12203 | |
| 19 | Investigator Site | Dresden | Germany | 01069 | |
| 20 | Investigator Site | Hamburg | Germany | 20251 | |
| 21 | Investigator Site | Hamburg | Germany | 20253 | |
| 22 | Investigator Site | Hannover | Germany | 30159 | |
| 23 | Investigator Site | Schwerin | Germany | 19053 | |
| 24 | Investigator Site | Schwerin | Germany | 19055 | |
| 25 | Investigator Site | Budapest | Hungary | 1134 | |
| 26 | Investigator Site | Szeged | Hungary | 6725 | |
| 27 | Investigator Site | Törökbálint | Hungary | 2045 | |
| 28 | Investigator Site | Beer Sheva | Israel | 84101 | |
| 29 | Investigator Site | Haifa | Israel | 31096 | |
| 30 | Investigator Site | Barcelona | Spain | 08017 | |
| 31 | Investigator Site | Barcelona | Spain | 08035 | |
| 32 | Investigator Site | Madrid | Spain | 28036 | |
| 33 | Investigator Site | Zaragoza | Spain | 50015 | |
| 34 | Investigator Site | Göteborg | Sweden | 413 90 | |
| 35 | Investigator Site | Örebro | Sweden | 701 85 |
Sponsors and Collaborators
- Idorsia Pharmaceuticals Ltd.
Investigators
- Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT02839200
Other Study ID Numbers:
- AC-078A201
First Posted:
Jul 20, 2016
Last Update Posted:
Apr 13, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Idorsia Pharmaceuticals Ltd.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Conducted at 38 sites in 6 countries (Germany, Hungary, Israel, Spain, Sweden, and the USA) |
|---|---|
| Pre-assignment Detail | Screening details: screening period (screening visit followed by at least 7 days at home) and a run-in period (2 PSG nights on single-blind placebo, followed by 5-12 days with no treatment), and lasting a max. of 28 days. N = 360 subjects were randomized; N = 359 subjects were treated; N = 1 subject discontinued due to "randomization error". |
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules |
| Period Title: Overall Study | ||||||
| STARTED | 60 | 59 | 60 | 61 | 60 | 60 |
| COMPLETED | 56 | 58 | 59 | 61 | 58 | 59 |
| NOT COMPLETED | 4 | 1 | 1 | 0 | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules | Total of all reporting groups |
| Overall Participants | 60 | 58 | 60 | 61 | 60 | 60 | 359 |
| Age (years) [Median (Full Range) ] | |||||||
| Median (Full Range) [years] |
41
|
48
|
48
|
46
|
43
|
48
|
47
|
| Age, Customized (Count of Participants) | |||||||
| Adults (18-64 years) |
60
100%
|
58
100%
|
60
100%
|
61
100%
|
60
100%
|
60
100%
|
359
100%
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
38
63.3%
|
38
65.5%
|
39
65%
|
39
63.9%
|
38
63.3%
|
38
63.3%
|
230
64.1%
|
| Male |
22
36.7%
|
20
34.5%
|
21
35%
|
22
36.1%
|
22
36.7%
|
22
36.7%
|
129
35.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
9
15%
|
3
5.2%
|
9
15%
|
5
8.2%
|
4
6.7%
|
9
15%
|
39
10.9%
|
| Not Hispanic or Latino |
51
85%
|
54
93.1%
|
51
85%
|
56
91.8%
|
56
93.3%
|
51
85%
|
319
88.9%
|
| Unknown or Not Reported |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.7%
|
1
0.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Black or African American |
5
8.3%
|
8
13.8%
|
4
6.7%
|
5
8.2%
|
6
10%
|
7
11.7%
|
35
9.7%
|
| White |
54
90%
|
49
84.5%
|
56
93.3%
|
56
91.8%
|
54
90%
|
52
86.7%
|
321
89.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
Outcome Measures
| Title | Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2 |
|---|---|
| Description | WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG) |
| Time Frame | Baseline and Days 1&2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules |
| Measure Participants | 60 | 58 | 60 | 61 | 60 | 60 |
| Least Squares Mean (Standard Error) [minutes] |
-28.4
(4.24)
|
-32.3
(4.32)
|
-37.7
(4.25)
|
-47.1
(4.21)
|
-29.9
(4.30)
|
-21.4
(4.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg, ACT-541468 50 mg, Placebo |
|---|---|---|
| Comments | Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of "no dose-response" was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package "DoseFinding" (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.) | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Multiple Comparison Procedure-Model | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ACT-541468 5 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.241 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -7 | |
| Confidence Interval |
(2-Sided) 95% -18.7 to 4.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.95 |
|
| Estimation Comments | Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ACT-541468 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.072 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -10.8 | |
| Confidence Interval |
(2-Sided) 95% -22.6 to 1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6 |
|
| Estimation Comments | Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | ACT-541468 25 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -16.2 | |
| Confidence Interval |
(2-Sided) 95% -27.9 to -4.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.95 |
|
| Estimation Comments | Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | ACT-541468 50 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -25.6 | |
| Confidence Interval |
(2-Sided) 95% -37.3 to -13.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.92 |
|
| Estimation Comments | Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Zolpidem, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.155 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -8.5 | |
| Confidence Interval |
(2-Sided) 95% -20.4 to 3.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.97 |
|
| Estimation Comments | Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean | |
| Title | Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2 |
|---|---|
| Description | LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG |
| Time Frame | Baseline and Days 1&2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules |
| Measure Participants | 60 | 58 | 60 | 61 | 60 | 60 |
| Mean (Standard Deviation) [Minutes] |
-26.88
(45.42)
|
-29.31
(26.79)
|
-36.14
(34.34)
|
-36.41
(26.71)
|
-45.14
(32.82)
|
-22.02
(46.63)
|
| Title | Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4 |
|---|---|
| Description | sLSO is the self-reported time to fall asleep, as reported in the sleep diary |
| Time Frame | Baseline and Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules |
| Measure Participants | 60 | 58 | 60 | 61 | 60 | 60 |
| Mean (Standard Deviation) [Minutes] |
-13.38
(27.79)
|
-21.07
(24.26)
|
-15.50
(25.51)
|
-23.65
(24.12)
|
-19.98
(19.28)
|
-16.32
(21.16)
|
| Title | Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4 |
|---|---|
| Description | sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary. |
| Time Frame | Baseline and Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules |
| Measure Participants | 51 | 45 | 53 | 49 | 48 | 50 |
| Mean (Standard Deviation) [Minutes] |
-31.32
(33.32)
|
-24.35
(33.4)
|
-29.8
(39.88)
|
-35.45
(37.53)
|
-29.08
(27.28)
|
-23.61
(32.62)
|
Adverse Events
| Time Frame | Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs). | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo | ||||||
| Arm/Group Description | Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg Placebo 1: Placebo capsules matching ACT-541468 capsules | Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg | Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg Placebo 2: Placebo capsules matching over-encapsulated zolpidem | Each subject received two placebo capsules, once daily in the evening for 4 weeks Placebo 1: Placebo capsules matching ACT-541468 capsules | ||||||
All Cause Mortality |
||||||||||||
| ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/58 (0%) | 0/60 (0%) | 0/61 (0%) | 0/60 (0%) | 0/60 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 2/58 (3.4%) | 0/60 (0%) | 1/61 (1.6%) | 0/60 (0%) | 0/60 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| Myocardial infarction | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| Accident at work | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Craniocerebral injury | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Angioedema | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| ACT-541468 5 mg | ACT-541468 10 mg | ACT-541468 25 mg | ACT-541468 50 mg | Zolpidem | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/60 (35%) | 22/58 (37.9%) | 23/60 (38.3%) | 21/61 (34.4%) | 24/60 (40%) | 18/60 (30%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Eosinophilia | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Neutropenia | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Arrhythmia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Atrial tachycardia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Atrioventricular block first degree | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Defect conduction intraventricular | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Palpitations | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Sinus bradycardia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Ventricular extrasystoles | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Ear and labyrinth disorders | ||||||||||||
| Ear pain | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Paraesthesia ear | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Vertigo | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 1/60 (1.7%) | 1 |
| Eye disorders | ||||||||||||
| Chromatopsia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Vision blurred | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal discomfort | 1/60 (1.7%) | 1 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Abdominal distension | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Abdominal pain upper | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 4/60 (6.7%) | 5 | 1/60 (1.7%) | 3 |
| Constipation | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Diarrhoea | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 3/60 (5%) | 3 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 2/60 (3.3%) | 2 |
| Dry mouth | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Dyspepsia | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Faeces pale | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Flatulence | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Nausea | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 2/60 (3.3%) | 2 | 1/61 (1.6%) | 1 | 4/60 (6.7%) | 5 | 0/60 (0%) | 0 |
| General disorders | ||||||||||||
| Chest discomfort | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Fatigue | 1/60 (1.7%) | 2 | 1/58 (1.7%) | 1 | 3/60 (5%) | 3 | 0/61 (0%) | 0 | 4/60 (6.7%) | 5 | 2/60 (3.3%) | 2 |
| Feeling hot | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 2 |
| Gait disturbance | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 2/60 (3.3%) | 2 | 1/60 (1.7%) | 1 |
| Influenza like illness | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Medical device site erythema | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Medical device site inflammation | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Medical device site irritation | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Medical device site pain | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Pyrexia | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Cholelithiasis | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Immune system disorders | ||||||||||||
| Seasonal allergy | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Infections and infestations | ||||||||||||
| Acute sinusitis | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Gastroenteritis | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Gastroenteritis viral | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Helicobacter infection | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Influenza | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Nasopharyngitis | 2/60 (3.3%) | 2 | 2/58 (3.4%) | 2 | 0/60 (0%) | 0 | 2/61 (3.3%) | 2 | 5/60 (8.3%) | 5 | 4/60 (6.7%) | 4 |
| Pharyngitis | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Rash pustular | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Tonsillitis | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Tooth infection | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Upper respiratory tract infection | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Vulvovaginal mycotic infection | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||
| Fall | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Hand fracture | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Joint injury | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Ligament sprain | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Limb injury | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 2/60 (3.3%) | 2 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Aspartate aminotransferase increased | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Bilirubin conjugated increased | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Blood bilirubin increased | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Blood calcium decreased | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 2/60 (3.3%) | 2 |
| Blood cholesterol increased | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Blood creatine phosphokinase increased | 2/60 (3.3%) | 2 | 1/58 (1.7%) | 2 | 1/60 (1.7%) | 1 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| ECG signs of myocardial infarction | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Electrocardiogram QT prolonged | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Electrocardiogram T wave inversion | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Gamma-glutamyltransferase increased | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 2/60 (3.3%) | 2 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Weight increased | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| White blood cell count decreased | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Hyperkalaemia | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Hypocalcaemia | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Increased appetite | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Back pain | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Muscle tightness | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Myalgia | 0/60 (0%) | 0 | 1/58 (1.7%) | 2 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Neck pain | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Pain in extremity | 1/60 (1.7%) | 1 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Balance disorder | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Cervicobrachial syndrome | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Dizziness | 1/60 (1.7%) | 1 | 2/58 (3.4%) | 4 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 4/60 (6.7%) | 4 | 1/60 (1.7%) | 1 |
| Dizziness postural | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Dysarthria | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Dysgeusia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Headache | 6/60 (10%) | 7 | 5/58 (8.6%) | 5 | 5/60 (8.3%) | 5 | 5/61 (8.2%) | 6 | 6/60 (10%) | 8 | 1/60 (1.7%) | 1 |
| Hypersomnia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Somnolence | 3/60 (5%) | 4 | 3/58 (5.2%) | 3 | 4/60 (6.7%) | 5 | 4/61 (6.6%) | 5 | 3/60 (5%) | 3 | 3/60 (5%) | 3 |
| Psychiatric disorders | ||||||||||||
| Abnormal dreams | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Anxiety | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Insomnia | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Nervousness | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Nightmare | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Stress | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Bladder discomfort | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Nephrolithiasis | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Nocturia | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Renal pain | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| Dysmenorrhoea | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 1/60 (1.7%) | 2 | 0/60 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 2 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Epistaxis | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 1/60 (1.7%) | 1 | 0/60 (0%) | 0 |
| Nasal congestion | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Oropharyngeal pain | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 1/60 (1.7%) | 1 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Pharyngeal erythema | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Productive cough | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Acne | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
| Dermatitis contact | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Erythema | 2/60 (3.3%) | 2 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Photosensitivity reaction | 1/60 (1.7%) | 1 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Pruritus | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 2/61 (3.3%) | 2 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Pruritus generalised | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Urticaria | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 1/61 (1.6%) | 1 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||
| Coronary arterial stent insertion | 0/60 (0%) | 0 | 1/58 (1.7%) | 1 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 0/60 (0%) | 0 |
| Vascular disorders | ||||||||||||
| Hot flush | 0/60 (0%) | 0 | 0/58 (0%) | 0 | 0/60 (0%) | 0 | 0/61 (0%) | 0 | 0/60 (0%) | 0 | 1/60 (1.7%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Trial Disclosure Desk |
|---|---|
| Organization | Idorsia Pharmaceuticals |
| Phone | +41 588 441977 |
| clinical-trials-disclosure@idorsia.com |
Responsible Party:
Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT02839200
Other Study ID Numbers:
- AC-078A201
First Posted:
Jul 20, 2016
Last Update Posted:
Apr 13, 2020
Last Verified:
Apr 1, 2020