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Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606593
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : March 11, 2013
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Midnight Pharma, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Primary Insomnia
Interventions Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo
Drug: ACT-078573 and matching placebo
Enrollment 112
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.
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.
Arm/Group Title Treatment Sequence 200/100/P/50/25 Treatment Sequence 100/50/200/25/P Treatment Sequence 50/25/100/P/200 Treatment Sequence 25/P/50/200/100 Treatment Sequence P/200/25/100/50 Treatment Sequence 25/50/P/100/200 Treatment Sequence P/25/200/50/100 Treatment Sequence 200/P/100/25/50 Treatment Sequence 100/200/50/P/25 Treatment Sequence 50/100/25/200/P
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 11 [1] 11 [1] 11 [1] 11 [1] 12 [1] 11 [1] 11 [1] 11 [2] 12 [1] 11 [1]
1st Double-blind Treatment 11 11 11 11 12 11 11 11 12 11
2nd Double-blind Treatment 11 11 11 10 12 11 10 9 12 11
3rd Double-blind Treatment 11 11 10 10 11 11 10 9 12 11
4th Double-blind Treatment 10 11 10 10 11 11 10 9 11 11
5th Double-blind Treatment 10 11 9 10 11 11 10 9 11 11
Completed 10 11 9 10 11 11 10 9 11 11
Not Completed 1 0 2 1 1 0 1 2 1 0
Reason Not Completed
Adverse Event             0             0             0             1             1             0             1             2             1             0
Withdrawal of consent             1             0             1             0             0             0             0             0             0             0
Administrative/Other             0             0             1             0             0             0             0             0             0             0
[1]
Randomized participants
[2]
Randomized participants. One participant actually received the treatment sequence 200/P/100/ 50/25
Arm/Group Title Patient Flow
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants
72.0  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
78
  69.6%
Male
34
  30.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 112 participants
112
1.Primary Outcome
Title Mean Wake Time After Sleep Onset (WASO)
Hide Description

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).

Time Frame 2 treatment nights
Hide Outcome Measure Data
Hide Analysis Population Description
Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.
Arm/Group Title Placebo ACT-078573 25 mg ACT-078573 50 mg ACT-078573 100 mg ACT-078573 200 mg
Hide Arm/Group Description:
Two capsules containing placebo, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
Overall Number of Participants Analyzed 100 100 100 100 100
Mean (Standard Deviation)
Unit of Measure: minutes
109.1  (36.0) 98.7  (35.5) 90.0  (35.7) 77.7  (33.2) 62.6  (27.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-17.0 to -3.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value -19.2
Confidence Interval (2-Sided) 95%
-25.7 to -12.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value -31.4
Confidence Interval (2-Sided) 95%
-38.0 to -24.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value -46.5
Confidence Interval (2-Sided) 95%
-53.3 to -39.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Total Sleep Time (TST)
Hide Description

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).

Time Frame 2 treatment nights
Hide Outcome Measure Data
Hide Analysis Population Description
Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.
Arm/Group Title Placebo ACT-078573 25 mg ACT-078573 50 mg ACT-078573 100 mg ACT-078573 200 mg
Hide Arm/Group Description:
Two capsules containing placebo, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
Overall Number of Participants Analyzed 100 100 100 100 100
Mean (Standard Deviation)
Unit of Measure: minutes
339.7  (43.2) 353.8  (40.1) 360.9  (41.7) 374.2  (39.6) 394.7  (34.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 25 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
7.4 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value 21.5
Confidence Interval (2-Sided) 95%
14.6 to 28.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value 34.7
Confidence Interval (2-Sided) 95%
27.8 to 41.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ACT-078573 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square means treatment effect
Estimated Value 55.1
Confidence Interval (2-Sided) 95%
48.2 to 62.0
Estimation Comments [Not Specified]
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.
Adverse Event Reporting Description Safety population
 
Arm/Group Title Single-blind Placebo Placebo ACT-078573 25 mg ACT-078573 50 mg ACT-078573 100 mg ACT-078573 200 mg
Hide Arm/Group Description Treatment administered during screening period Two capsules containing placebo, orally administered on each of 2 consecutive nights Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
All-Cause Mortality
Single-blind Placebo Placebo ACT-078573 25 mg ACT-078573 50 mg ACT-078573 100 mg ACT-078573 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Single-blind Placebo Placebo ACT-078573 25 mg ACT-078573 50 mg ACT-078573 100 mg ACT-078573 200 mg
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   0/112 (0.00%)      1/107 (0.93%)      0/106 (0.00%)      0/106 (0.00%)      0/106 (0.00%)      0/108 (0.00%)    
Musculoskeletal and connective tissue disorders             
PAIN IN EXTREMITY  1  0/112 (0.00%)  0 1/107 (0.93%)  1 0/106 (0.00%)  0 0/106 (0.00%)  0 0/106 (0.00%)  0 0/108 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single-blind Placebo Placebo ACT-078573 25 mg ACT-078573 50 mg ACT-078573 100 mg ACT-078573 200 mg
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   5/112 (4.46%)      12/107 (11.21%)      12/106 (11.32%)      10/106 (9.43%)      11/106 (10.38%)      10/108 (9.26%)    
Cardiac disorders             
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
SUPRAVENTRICULAR EXTRASYSTOLES  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Eye disorders             
CONJUNCTIVITIS  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
Gastrointestinal disorders             
DIARRHOEA  1  0/112 (0.00%)  2/107 (1.87%)  1/106 (0.94%)  1/106 (0.94%)  0/106 (0.00%)  1/108 (0.93%) 
NAUSEA  1  1/112 (0.89%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  1/108 (0.93%) 
DRY MOUTH  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
ABDOMINAL PAIN UPPER  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
CONSTIPATION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
General disorders             
FATIGUE  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  2/106 (1.89%)  0/108 (0.00%) 
GAIT DISTURBANCE  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
ASTHENIA  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Immune system disorders             
SEASONAL ALLERGY  1  1/112 (0.89%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Infections and infestations             
BRONCHITIS  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
EAR INFECTION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
EYE INFECTION  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
EYE INFECTION VIRAL  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
GASTROENTERITIS  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
SINUSITIS  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Injury, poisoning and procedural complications             
EXCORIATION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  1/108 (0.93%) 
CONTUSION  1  1/112 (0.89%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
EYE INJURY  1  1/112 (0.89%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
FALL  1  1/112 (0.89%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Investigations             
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
BLOOD CREATININE INCREASED  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
BLOOD GLUCOSE INCREASED  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
BLOOD UREA INCREASED  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
ALANINE AMINOTRANSFERASE INCREASED  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Musculoskeletal and connective tissue disorders             
BACK PAIN  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
EXOSTOSIS  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
MUSCLE SPASMS  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
MUSCULAR WEAKNESS  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
MUSCULOSKELETAL STIFFNESS  1  1/112 (0.89%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Nervous system disorders             
SOMNOLENCE  1  0/112 (0.00%)  0/107 (0.00%)  4/106 (3.77%)  1/106 (0.94%)  2/106 (1.89%)  2/108 (1.85%) 
HEADACHE  1  2/112 (1.79%)  2/107 (1.87%)  0/106 (0.00%)  3/106 (2.83%)  1/106 (0.94%)  0/108 (0.00%) 
DEPRESSED LEVEL OF CONSCIOUSNESS  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
DIZZINESS  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  1/108 (0.93%) 
BALANCE DISORDER  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
SEDATION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
Renal and urinary disorders             
POLLAKIURIA  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
URETHRAL PAIN  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
URINARY INCONTINENCE  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
Respiratory, thoracic and mediastinal disorders             
COUGH  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
HICCUPS  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
RHINITIS SEASONAL  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/108 (0.00%) 
SINUS CONGESTION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
Skin and subcutaneous tissue disorders             
SKIN IRRITATION  1  0/112 (0.00%)  0/107 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
RASH ERYTHEMATOUS  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  1/108 (0.93%) 
PHOTOSENSITIVITY REACTION  1  0/112 (0.00%)  0/107 (0.00%)  0/106 (0.00%)  1/106 (0.94%)  0/106 (0.00%)  0/108 (0.00%) 
DRY SKIN  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
RASH  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Vascular disorders             
HYPERTENSION  1  0/112 (0.00%)  1/107 (0.93%)  0/106 (0.00%)  0/106 (0.00%)  0/106 (0.00%)  0/108 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Pascal Charef/Clinical Trial Leader
Organization: Actelion Pharmaceuticals Ltd
Phone: +41 61 565 65 65
Layout table for additonal information
Responsible Party: Midnight Pharma, LLC
ClinicalTrials.gov Identifier: NCT00606593    
Other Study ID Numbers: AC-057A201
First Submitted: January 4, 2008
First Posted: February 4, 2008
Results First Submitted: December 21, 2012
Results First Posted: March 11, 2013
Last Update Posted: March 14, 2016