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Trial record 15 of 16 for:    ZOLPIDEM AND Chronic Insomnia

Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia (RESTORA 1)

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: NCT00608985
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : February 7, 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: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Insomnia
Interventions Drug: almorexant
Drug: Placebo
Drug: zolpidem
Enrollment 709
Recruitment Details First subject, first visit was on 28 April 2008. The last subject, last visit (safety follow-up) was on 30 September 2009.
Pre-assignment Details There was a screening period of 14 to 28 days. Two randomized subjects (one in each almorexant (ACT-078573) dose group) did not receive double-blind study treatment. The 'Started population' was defined as those participants who were randomized and treated.
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Period Title: Overall Study
Started 177 [1] 186 [1] 176 [1] 168 [1]
Completed Double-blind Treatment 163 174 171 161
Completed 161 [2] 173 [2] 170 [2] 159 [2]
Not Completed 16 13 6 9
Reason Not Completed
Adverse Event             2             7             4             6
Administrative/Other             7             4             1             2
Withdrawal of Consent             5             1             1             1
Lost to Follow-up             2             1             0             0
[1]
Randomized and started double-blind treatment
[2]
Completed follow-up
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg Total
Hide Arm/Group Description

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Total of all reporting groups
Overall Number of Baseline Participants 177 186 176 168 707
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 186 participants 176 participants 168 participants 707 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
177
 100.0%
186
 100.0%
176
 100.0%
168
 100.0%
707
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 177 participants 186 participants 176 participants 168 participants 707 participants
46.2  (11.69) 44.1  (12.44) 46.1  (11.83) 45.1  (12.11) 45.4  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 186 participants 176 participants 168 participants 707 participants
Female
111
  62.7%
113
  60.8%
106
  60.2%
106
  63.1%
436
  61.7%
Male
66
  37.3%
73
  39.2%
70
  39.8%
62
  36.9%
271
  38.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 186 participants 176 participants 168 participants 707 participants
Australia 13 15 12 14 54
Austria 3 5 2 4 14
Belgium 0 1 1 0 2
Bulgaria 1 0 1 0 2
Czech Republic 2 2 1 1 6
Denmark 6 5 5 4 20
Finland 13 14 13 14 54
France 3 2 3 2 10
Germany 83 86 87 81 337
Hungary 12 11 11 13 47
Israel 5 5 6 5 21
Italy 3 3 2 2 10
Poland 3 3 3 3 12
South Africa 15 13 13 12 53
Spain 4 6 5 3 18
Sweden 6 8 5 6 25
Switzerland 1 4 4 1 10
United Kingdom 4 3 2 3 12
1.Primary Outcome
Title Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
Hide Description

WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.

For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16

Time Frame From baseline to Day 1&2
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description:

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Overall Number of Participants Analyzed 177 186 176 168
Median (95% Confidence Interval)
Unit of Measure: minutes
Baseline
85.0
(77.3 to 91.0)
86.6
(80.0 to 92.3)
92.3
(84.8 to 98.3)
76.5
(69.3 to 82.0)
Day 1&2
72.8
(63.3 to 81.8)
54.5
(47.3 to 61.0)
46.4
(41.8 to 49.8)
54.6
(49.0 to 62.5)
Change from baseline to day 1&2
-11.8
(-19.3 to -7.3)
-29.0
(-33.0 to -23.3)
-40.4
(-47.5 to -31.5)
-17.9
(-25.3 to -12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 100mg
Comments Change from baseline to day 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -15.0
Confidence Interval (2-Sided) 95%
-21.8 to -8.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 200mg
Comments Change from baseline to day 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -26.8
Confidence Interval (2-Sided) 95%
-34.3 to -19.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Zolpidem 10mg
Comments Change from baseline to day 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0376
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -6.8
Confidence Interval (2-Sided) 95%
-13.5 to -0.3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to Day 15&16 in WASO
Hide Description

WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.

For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16

Time Frame From baseline to Day 15&16
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description:

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Overall Number of Participants Analyzed 177 186 176 168
Median (95% Confidence Interval)
Unit of Measure: minutes
Baseline
85.0
(77.3 to 91.0)
86.6
(80.0 to 92.3)
92.3
(84.8 to 98.3)
76.5
(69.3 to 82.0)
Day 15&16
65.0
(56.0 to 71.5)
55.8
(50.5 to 59.0)
51.8
(46.3 to 56.0)
63.0
(56.5 to 72.5)
Change from baseline to Day 15&16
-18.3
(-22.0 to -12.0)
-29.6
(-33.5 to -23.8)
-36.3
(-43.8 to -26.5)
-15.1
(-19.0 to -8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 100mg
Comments Change from baseline to day 15&16 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -13.5
Confidence Interval (2-Sided) 95%
-20.3 to -6.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 200mg
Comments Change from baseline to day 15&16 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -19.5
Confidence Interval (2-Sided) 95%
-27.3 to -12.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Zolpidem 10mg
Comments Change from baseline to day 15&16 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3358
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-3.8 to 11.0
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
Hide Description sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2
Time Frame From baseline to Week 1&2
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients with available data
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description:

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Overall Number of Participants Analyzed 175 179 173 168
Median (95% Confidence Interval)
Unit of Measure: minutes
Baseline
64.0
(60.0 to 75.0)
65.0
(59.5 to 72.0)
69.0
(63.0 to 77.0)
61.6
(55.0 to 70.9)
Week 1&2
52.9
(47.5 to 58.1)
40.5
(34.5 to 48.3)
42.9
(37.5 to 47.5)
30.5
(25.9 to 39.6)
Change from baseline to week 1&2
-14.1
(-20.0 to -9.2)
-19.5
(-22.9 to -12.7)
-21.8
(-28.8 to -17.5)
-23.4
(-27.5 to -19.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 100mg
Comments Change from baseline to week 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -7.3
Confidence Interval (2-Sided) 95%
-13.3 to -1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 200mg
Comments Change from baseline to week 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-16.4 to -4.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Zolpidem 10mg
Comments Change from baseline to week 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -12.7
Confidence Interval (2-Sided) 95%
-18.8 to -6.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)
Hide Description LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Time Frame From baseline to Day 1&2
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description:

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Overall Number of Participants Analyzed 177 186 176 168
Median (95% Confidence Interval)
Unit of Measure: minutes
Baseline
57.3
(53.0 to 65.5)
57.4
(52.0 to 63.3)
54.1
(47.5 to 58.3)
56.5
(52.3 to 66.0)
Day 1&2
37.5
(32.3 to 44.0)
28.8
(25.0 to 34.5)
25.0
(22.3 to 28.3)
22.5
(20.3 to 26.8)
Change from baseline to day 1&2
-15.8
(-19.5 to -11.0)
-24.8
(-29.8 to -18.3)
-22.5
(-27.5 to -20.5)
-29.4
(-35.8 to -25.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 100mg
Comments Change from baseline to day 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -9.3
Confidence Interval (2-Sided) 95%
-15.3 to -3.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 200mg
Comments Change from baseline to day 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -9.5
Confidence Interval (2-Sided) 95%
-15.0 to -4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Zolpidem 10mg
Comments Change from baseline to day 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -16.0
Confidence Interval (2-Sided) 95%
-22.0 to -9.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Day 15&16 in LPS
Hide Description LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG
Time Frame From baseline to Day 15&16
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description:

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Overall Number of Participants Analyzed 177 186 176 168
Median (95% Confidence Interval)
Unit of Measure: minutes
Baseline
57.3
(53.0 to 65.5)
57.4
(52.0 to 63.3)
54.1
(47.5 to 58.3)
56.5
(52.3 to 66.0)
Day 15&16
30.0
(26.0 to 37.8)
29.3
(25.8 to 35.3)
24.1
(21.5 to 28.0)
24.6
(21.3 to 28.3)
Change from baseline to day 15&16
-20.0
(-25.8 to -16.3)
-23.5
(-31.0 to -20.0)
-26.5
(-30.8 to -22.8)
-32.3
(-36.0 to -26.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 100mg
Comments Change from baseline to day 15&16 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2237
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-11.0 to 2.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 200mg
Comments Change from baseline to day 15&16 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0607
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-12.3 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Zolpidem 10mg
Comments Change from baseline to day 15&16 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -10.5
Confidence Interval (2-Sided) 95%
-17.3 to -4.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)
Hide Description sLSO was the self-reported time to fall asleep as reported in the sleep diary
Time Frame From baseline to Week 1&2
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients with available data
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description:

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Overall Number of Participants Analyzed 175 179 173 168
Median (95% Confidence Interval)
Unit of Measure: minutes
Baseline
58.8
(52.0 to 64.5)
55.0
(49.0 to 60.6)
53.3
(50.5 to 58.4)
50.5
(45.2 to 57.0)
Week 1&2
45.0
(39.2 to 51.0)
36.5
(32.9 to 41.7)
34.5
(31.5 to 38.3)
33.3
(31.1 to 37.2)
Change from baseline to week 1&2
-10.0
(-15.1 to -4.7)
-16.2
(-19.3 to -12.4)
-16.2
(-19.9 to -13.5)
-17.2
(-19.9 to -12.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 100mg
Comments Change from baseline to week 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1187
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-9.1 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Almorexant 200mg
Comments Change from baseline to week 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -7.1
Confidence Interval (2-Sided) 95%
-11.5 to -2.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Zolpidem 10mg
Comments Change from baseline to week 1&2 compared with placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0121
Comments [Not Specified]
Method Wilcoxon rank-sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -6.1
Confidence Interval (2-Sided) 95%
-10.8 to -1.4
Estimation Comments [Not Specified]
Time Frame All adverse events occurring after the start of study treatment and within 24 hours after the last dose of study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Hide Arm/Group Description

Placebo

Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem

almorexant 100 mg

almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem

almorexant 200 mg

almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem

zolpidem 10 mg

zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

All-Cause Mortality
Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/177 (0.00%)      2/186 (1.08%)      1/176 (0.57%)      0/168 (0.00%)    
Infections and infestations         
ABSCESS LIMB  1  0/177 (0.00%)  0 1/186 (0.54%)  1 0/176 (0.00%)  0 0/168 (0.00%)  0
Nervous system disorders         
MULTIPLE SCLEROSIS  1  0/177 (0.00%)  0 1/186 (0.54%)  1 0/176 (0.00%)  0 0/168 (0.00%)  0
Renal and urinary disorders         
CALCULUS URETERIC  1  0/177 (0.00%)  0 0/186 (0.00%)  0 1/176 (0.57%)  1 0/168 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Almorexant 100mg Almorexant 200mg Zolpidem 10mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/177 (36.16%)      65/186 (34.95%)      61/176 (34.66%)      72/168 (42.86%)    
Cardiac disorders         
PALPITATIONS  1  1/177 (0.56%)  1/186 (0.54%)  1/176 (0.57%)  2/168 (1.19%) 
Ear and labyrinth disorders         
VERTIGO  1  0/177 (0.00%)  1/186 (0.54%)  1/176 (0.57%)  2/168 (1.19%) 
Eye disorders         
BLEPHAROSPASM  1  0/177 (0.00%)  0/186 (0.00%)  2/176 (1.14%)  0/168 (0.00%) 
VISION BLURRED  1  3/177 (1.69%)  0/186 (0.00%)  1/176 (0.57%)  1/168 (0.60%) 
Gastrointestinal disorders         
NAUSEA  1  7/177 (3.95%)  4/186 (2.15%)  6/176 (3.41%)  4/168 (2.38%) 
DIARRHOEA  1  1/177 (0.56%)  6/186 (3.23%)  1/176 (0.57%)  2/168 (1.19%) 
ABDOMINAL PAIN UPPER  1  3/177 (1.69%)  3/186 (1.61%)  2/176 (1.14%)  1/168 (0.60%) 
CONSTIPATION  1  0/177 (0.00%)  2/186 (1.08%)  0/176 (0.00%)  0/168 (0.00%) 
DRY MOUTH  1  1/177 (0.56%)  1/186 (0.54%)  0/176 (0.00%)  3/168 (1.79%) 
DYSPEPSIA  1  2/177 (1.13%)  0/186 (0.00%)  1/176 (0.57%)  1/168 (0.60%) 
General disorders         
FATIGUE  1  2/177 (1.13%)  9/186 (4.84%)  6/176 (3.41%)  6/168 (3.57%) 
ASTHENIA  1  2/177 (1.13%)  5/186 (2.69%)  3/176 (1.70%)  1/168 (0.60%) 
CHEST DISCOMFORT  1  1/177 (0.56%)  1/186 (0.54%)  1/176 (0.57%)  1/168 (0.60%) 
Infections and infestations         
NASOPHARYNGITIS  1  3/177 (1.69%)  5/186 (2.69%)  2/176 (1.14%)  5/168 (2.98%) 
INFLUENZA  1  0/177 (0.00%)  2/186 (1.08%)  0/176 (0.00%)  0/168 (0.00%) 
Investigations         
WEIGHT INCREASED  1  0/177 (0.00%)  0/186 (0.00%)  3/176 (1.70%)  1/168 (0.60%) 
Metabolism and nutrition disorders         
FOOD CRAVING  1  0/177 (0.00%)  0/186 (0.00%)  2/176 (1.14%)  0/168 (0.00%) 
Musculoskeletal and connective tissue disorders         
MUSCLE SPASMS  1  2/177 (1.13%)  1/186 (0.54%)  1/176 (0.57%)  0/168 (0.00%) 
Nervous system disorders         
HEADACHE  1  21/177 (11.86%)  18/186 (9.68%)  26/176 (14.77%)  29/168 (17.26%) 
DIZZINESS  1  10/177 (5.65%)  6/186 (3.23%)  8/176 (4.55%)  3/168 (1.79%) 
SOMNOLENCE  1  4/177 (2.26%)  6/186 (3.23%)  5/176 (2.84%)  4/168 (2.38%) 
BALANCE DISORDER  1  0/177 (0.00%)  1/186 (0.54%)  2/176 (1.14%)  2/168 (1.19%) 
DYSGEUSIA  1  1/177 (0.56%)  1/186 (0.54%)  1/176 (0.57%)  3/168 (1.79%) 
PARAESTHESIA  1  2/177 (1.13%)  1/186 (0.54%)  1/176 (0.57%)  2/168 (1.19%) 
Psychiatric disorders         
DEPRESSED MOOD  1  0/177 (0.00%)  2/186 (1.08%)  1/176 (0.57%)  3/168 (1.79%) 
CONFUSIONAL STATE  1  1/177 (0.56%)  1/186 (0.54%)  1/176 (0.57%)  2/168 (1.19%) 
NIGHTMARE  1  2/177 (1.13%)  0/186 (0.00%)  2/176 (1.14%)  1/168 (0.60%) 
ANXIETY  1  0/177 (0.00%)  1/186 (0.54%)  1/176 (0.57%)  2/168 (1.19%) 
RESTLESSNESS  1  0/177 (0.00%)  0/186 (0.00%)  2/176 (1.14%)  0/168 (0.00%) 
Renal and urinary disorders         
MICTURITION URGENCY  1  0/177 (0.00%)  1/186 (0.54%)  1/176 (0.57%)  0/168 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
OROPHARYNGEAL PAIN  1  1/177 (0.56%)  2/186 (1.08%)  0/176 (0.00%)  2/168 (1.19%) 
COUGH  1  1/177 (0.56%)  0/186 (0.00%)  1/176 (0.57%)  2/168 (1.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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: Ouali Berkani/Clinical Trial Leader
Organization: Actelion Pharmaceuticals Ltd
Phone: +41 61 565 5342
Layout table for additonal information
Responsible Party: Midnight Pharma, LLC
ClinicalTrials.gov Identifier: NCT00608985     History of Changes
Other Study ID Numbers: AC-057A301
First Submitted: January 11, 2008
First Posted: February 6, 2008
Results First Submitted: December 21, 2012
Results First Posted: February 7, 2013
Last Update Posted: March 14, 2016