Almorexant (ACT-078573) in Elderly Subjects With Chronic... | NCT00606593 | Trialant
NCT00606593
Sponsor
Midnight Pharma, LLC
Status
Completed
Last Update Posted
Mar 14, 2016Estimated
Enrollment
112Actual
Phase
Phase 2
Conditions
Chronic Primary Insomnia
Interventions
ACT-078573 oral capsules at 25 and 100 mg and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
ACT-078573 and matching placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00606593
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AC-057A201
Secondary IDs
Not provided
Brief Title
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Official Title
Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia
Acronym
Not provided
Organization
Midnight Pharma, LLCINDUSTRY
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2007
Primary Completion Date
Apr 2008Actual
Completion Date
May 2008Actual
First Submitted Date
Jan 4, 2008
First Submission Date that Met QC Criteria
Jan 22, 2008
First Posted Date
Feb 4, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2012
Results First Submitted that Met QC Criteria
Feb 6, 2013
Results First Posted Date
Mar 11, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 11, 2010
Certification/Extension First Submitted that Passed QC Review
Feb 11, 2010
Certification/Extension First Posted Date
Feb 15, 2010Estimated
Last Update Submitted Date
Feb 11, 2016
Last Update Posted Date
Mar 14, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Midnight Pharma, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Primary Insomnia
Keywords
insomnia
elderly
sleeplessness
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABECD
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo
BCADE
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
CDBEA
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
DECAB
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
EADBC
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
DCEBA
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACT-078573 oral capsules at 25 and 100 mg and matching placebo
Drug
5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Wake Time After Sleep Onset (WASO)
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
2 treatment nights
Secondary Outcomes
Measure
Description
Time Frame
Mean Total Sleep Time (TST)
TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Elderly subjects (> 64 years) with a diagnosis of primary insomnia.
Exclusion Criteria:
History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I disorder other than primary insomnia.
Sleep apnea, or restless legs syndrome.
Daytime napping of more than 1 hour per day.
Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
65 Years
Maximum Age
Not provided
Standard Ages
Older Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
James K. Walsh, PhD
Sleep Medicine and Research Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Central Arkansas Research
Hot Springs
Arkansas
71913
United States
Pacific Sleep Medicine Services, Inc.
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of a 2-4-week screening phase on single-blind placebo, a 4-8-week treatment phase, and a 28 day safety follow-up. Subjects were randomized to one of 10 treatment sequences.
Recruitment Details
242 subjects were screened at 18 centers in the United States and received single-blind placebo treatment. The first subject screening visit was 12 Dec 2007, the first subject was treated on 19 Dec 2007. 112 subjects were randomized, the first assigned double-blind treatment, was on 26 Dec 2007. Last subject, last clinic visit ended on 4 Apr 2008.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Treatment Sequence 200/100/P/50/25
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
EDACB
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
AEBDC
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
BACED
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
CBDAE
Experimental
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Drug: ACT-078573 and matching placebo
ABECD
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BCADE
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CDBEA
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DECAB
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EADBC
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
DCEBA
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
EDACB
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
AEBDC
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
CBDAE
ACT-078573 and matching placebo
Drug
ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
BACED
2 treatment nights
Los Angeles
California
90048
United States
Pacific Sleep Medicine Services, Inc.
San Diego
California
92121
United States
California Clinical Trials Medical Group, Inc.
San Diego
California
92123
United States
PAB Clinical Research
Brandon
Florida
33511
United States
Miami Research Associates
Miami
Florida
33173
United States
OmniTrials
Naples
Florida
34110
United States
Broward Research Group & Sleep-Wake Disorders Center of South Florida
Pembroke Pines
Florida
33026
United States
Neurotrials Research, Inc.
Atlanta
Georgia
30342
United States
Sleep Disorders Center of Georgia
Atlanta
Georgia
30342
United States
Vince and Associates Clinical Research
Overland Park
Kansas
66212
United States
Community Research
Crestview Hills
Kentucky
41017
United States
Clinical Neurophysiology Services, P.C.
Troy
Michigan
48098
United States
Sleep Disorders & Research Center
Chesterfield
Missouri
63017
United States
Clinical Research Center of Nevada
Las Vegas
Nevada
89104
United States
Duke University
Durham
North Carolina
27710
United States
Tri-State Sleep Disorders Center
Cincinnati
Ohio
45227
United States
Cleveland Clinic Health Systems
Cleveland
Ohio
44195
United States
Lynn Health Sciences Institute
Oklahoma City
Oklahoma
73112
United States
Sleep Disorders Center
Columbia
South Carolina
29201
United States
Sleep Medicine Associates P.A.
Dallas
Texas
75231
United States
FG001
Treatment Sequence 100/50/200/25/P
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
FG002
Treatment Sequence 50/25/100/P/200
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
FG003
Treatment Sequence 25/P/50/200/100
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
FG004
Treatment Sequence P/200/25/100/50
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
FG005
Treatment Sequence 25/50/P/100/200
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
FG006
Treatment Sequence P/25/200/50/100
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
FG007
Treatment Sequence 200/P/100/25/50
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
FG008
Treatment Sequence 100/200/50/P/25
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
FG009
Treatment Sequence 50/100/25/200/P
Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
FG00011 subjectsRandomized participants
FG00111 subjectsRandomized participants
FG00211 subjectsRandomized participants
FG00311 subjectsRandomized participants
FG00412 subjectsRandomized participants
FG00511 subjectsRandomized participants
FG00611 subjectsRandomized participants
FG00711 subjectsRandomized participants. One participant actually received the treatment sequence 200/P/100/ 50/25
FG00812 subjectsRandomized participants
FG00911 subjectsRandomized participants
1st Double-blind Treatment
FG00011 subjects
FG00111 subjects
FG00211 subjects
FG00311 subjects
FG00412 subjects
FG00511 subjects
FG00611 subjects
FG00711 subjects
FG00812 subjects
FG00911 subjects
2nd Double-blind Treatment
FG00011 subjects
FG00111 subjects
FG00211 subjects
FG00310 subjects
FG00412 subjects
FG00511 subjects
FG00610 subjects
FG0079 subjects
FG00812 subjects
FG00911 subjects
3rd Double-blind Treatment
FG00011 subjects
FG00111 subjects
FG00210 subjects
FG00310 subjects
FG00411 subjects
FG00511 subjects
FG00610 subjects
FG0079 subjects
FG00812 subjects
FG00911 subjects
4th Double-blind Treatment
FG00010 subjects
FG00111 subjects
FG00210 subjects
FG00310 subjects
FG00411 subjects
FG00511 subjects
FG00610 subjects
FG0079 subjects
FG00811 subjects
FG00911 subjects
5th Double-blind Treatment
FG00010 subjects
FG00111 subjects
FG0029 subjects
FG00310 subjects
FG00411 subjects
FG00511 subjects
FG00610 subjects
FG0079 subjects
FG00811 subjects
FG00911 subjects
COMPLETED
FG00010 subjects
FG00111 subjects
FG0029 subjects
FG00310 subjects
FG00411 subjects
FG00511 subjects
FG00610 subjects
FG0079 subjects
FG00811 subjects
FG00911 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
Withdrawal of consent
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Administrative/Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Patient Flow
The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
Denominators
Units
Counts
Participants
BG000112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00072.0± 4.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00078
Male
BG00034
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG000112
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Wake Time After Sleep Onset (WASO)
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.
Posted
Mean
Standard Deviation
minutes
2 treatment nights
ID
Title
Description
OG000
Placebo
Two capsules containing placebo, orally administered on each of 2 consecutive nights
OG001
ACT-078573 25 mg
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
OG002
ACT-078573 50 mg
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
OG003
ACT-078573 100 mg
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
OG004
ACT-078573 200 mg
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
Units
Counts
Participants
OG000100
OG001100
OG002100
OG003
Title
Denominators
Categories
Title
Measurements
OG000109.1± 36.0
OG00198.7± 35.5
OG00290.0± 35.7
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Linear model
0.0018
Least square means treatment effect
-10.4
2-Sided
95
-17.0
-3.9
No
Superiority or Other
OG000
OG002
Linear model
<0.0001
Secondary
Mean Total Sleep Time (TST)
TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).
Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).
Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.
Posted
Mean
Standard Deviation
minutes
2 treatment nights
ID
Title
Description
OG000
Placebo
Two capsules containing placebo, orally administered on each of 2 consecutive nights
OG001
ACT-078573 25 mg
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
OG002
ACT-078573 50 mg
Time Frame
Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.
Description
Safety population
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Single-blind Placebo
Treatment administered during screening period
0
112
5
112
EG001
Placebo
Two capsules containing placebo, orally administered on each of 2 consecutive nights
1
107
12
107
EG002
ACT-078573 25 mg
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
0
106
12
106
EG003
ACT-078573 50 mg
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
0
106
10
106
EG004
ACT-078573 100 mg
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
0
106
11
106
EG005
ACT-078573 200 mg
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
0
108
10
108
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 events0 affected112 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected106 at risk
EG0030 events0 affected106 at risk
EG004
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
SOMNOLENCE
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0024 affected106 at risk
EG0031 affected106 at risk
EG0042 affected106 at risk
EG0052 affected108 at risk
HEADACHE
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected112 at risk
EG0012 affected107 at risk
EG0020 affected106 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0012 affected107 at risk
EG0021 affected106 at risk
EG003
FATIGUE
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
DEPRESSED LEVEL OF CONSCIOUSNESS
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
SKIN IRRITATION
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
ATRIOVENTRICULAR BLOCK SECOND DEGREE
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
BALANCE DISORDER
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
BLOOD UREA INCREASED
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
EXOSTOSIS
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
EYE INFECTION
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
EYE INFECTION VIRAL
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
PHOTOSENSITIVITY REACTION
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
RHINITIS SEASONAL
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
SEDATION
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
URETHRAL PAIN
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0021 affected106 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
ASTHENIA
General disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
EYE INJURY
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (11.0)
Systematic Assessment
EG0001 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
MUSCULOSKELETAL STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected112 at risk
EG0010 affected107 at risk
EG0020 affected106 at risk
EG003
SUPRAVENTRICULAR EXTRASYSTOLES
Cardiac disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected112 at risk
EG0011 affected107 at risk
EG0020 affected106 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Pascal Charef/Clinical Trial Leader
Actelion Pharmaceuticals Ltd
+41 61 565 65 65
ID
Term
D007319
Sleep Initiation and Maintenance Disorders
Ancestor Terms
ID
Term
D020919
Sleep Disorders, Intrinsic
D020920
Dyssomnias
D012893
Sleep Wake Disorders
D009422
Nervous System Diseases
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C519150
almorexant
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
100
OG004100
77.7
± 33.2
OG00462.6± 27.5
Least square means treatment effect
-19.2
2-Sided
95
-25.7
-12.6
No
Superiority or Other
OG000
OG003
Linear model
<0.0001
Least square means treatment effect
-31.4
2-Sided
95
-38.0
-24.9
No
Superiority or Other
OG000
OG004
Linear model
<0.0001
Least square means treatment effect
-46.5
2-Sided
95
-53.3
-39.9
No
Superiority or Other
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
OG003
ACT-078573 100 mg
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
OG004
ACT-078573 200 mg
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights