Trial Outcomes & Findings for A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150) (NCT NCT00770692)
NCT ID: NCT00770692
Last Updated: 2012-11-22
Results Overview
Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\*100. An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
COMPLETED
PHASE3
369 participants
Up to 25 weeks (24 weeks treatment period & 1 week follow-up)
2012-11-22
Participant Flow
181 non-elderly \& 188 elderly participants were enrolled in the screening period 1 week prior to the first dose. Among these, 20 non-elderly \& 24 elderly participants discontinued during the screening period. 161 non-elderly and 164 elderly participants enrolled. 1 elderly participant enrolled for treatment did not receive treatment.
Participant milestones
| Measure |
Eszopiclone 1 mg- Elderly
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
81
|
83
|
84
|
77
|
|
Overall Study
COMPLETED
|
69
|
74
|
70
|
66
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
14
|
11
|
Reasons for withdrawal
| Measure |
Eszopiclone 1 mg- Elderly
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
9
|
9
|
6
|
|
Overall Study
Adverse Event
|
3
|
0
|
4
|
4
|
|
Overall Study
Investigator judgment
|
2
|
0
|
1
|
1
|
Baseline Characteristics
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Baseline characteristics by cohort
| Measure |
Eszopiclone 1 mg- Elderly
n=80 Participants
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
n=83 Participants
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
n=84 Participants
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 Participants
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
70.4 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 17.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
185 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 25 weeks (24 weeks treatment period & 1 week follow-up)Population: Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.
Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)\*100. An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF.
Outcome measures
| Measure |
Eszopiclone 1 mg- Elderly
n=81 Participants
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
n=83 Participants
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
n=84 Participants
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 Participants
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
81.5 Percentage of Participants
|
79.5 Percentage of Participants
|
82.1 Percentage of Participants
|
87.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (screening period) and 4 weeks of treatmentPopulation: Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.
Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).
Outcome measures
| Measure |
Eszopiclone 1 mg- Elderly
n=80 Participants
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
n=83 Participants
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
n=84 Participants
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 Participants
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Mean Change From Baseline In Sleep Latency
Baseline
|
65.5 minutes
Standard Deviation 40.5
|
70.7 minutes
Standard Deviation 47.1
|
71.8 minutes
Standard Deviation 53.5
|
64.0 minutes
Standard Deviation 42.2
|
|
Mean Change From Baseline In Sleep Latency
Overall Period (Change From Baseline)
|
-32.1 minutes
Standard Deviation 35.6
|
-37.0 minutes
Standard Deviation 42.7
|
-36.7 minutes
Standard Deviation 51.8
|
-32.8 minutes
Standard Deviation 35.4
|
SECONDARY outcome
Timeframe: Baseline (screening period) and 4 weeks of treatmentPopulation: Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.
Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).
Outcome measures
| Measure |
Eszopiclone 1 mg- Elderly
n=80 Participants
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
n=83 Participants
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
n=84 Participants
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 Participants
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Wake Time After Sleep Onset (WASO)
Baseline
|
61.6 minutes
Standard Deviation 52.3
|
68.8 minutes
Standard Deviation 63.0
|
53.2 minutes
Standard Deviation 41.8
|
42.3 minutes
Standard Deviation 40.8
|
|
Mean Change From Baseline in Wake Time After Sleep Onset (WASO)
Overall Period (Change From Baseline)
|
-30.8 minutes
Standard Deviation 39.9
|
-35.1 minutes
Standard Deviation -25.0
|
-32.4 minutes
Standard Deviation 36.9
|
-23.3 minutes
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: Baseline (screening period) and 4 weeks of treatmentPopulation: Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.
Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).
Outcome measures
| Measure |
Eszopiclone 1 mg- Elderly
n=80 Participants
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
n=83 Participants
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
n=84 Participants
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 Participants
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Total Sleep Time
Baseline
|
314.2 minutes
Standard Deviation 73.2
|
307.9 minutes
Standard Deviation 60.0
|
290.7 minutes
Standard Deviation 44.0
|
308.2 minutes
Standard Deviation 57.7
|
|
Mean Change From Baseline in Total Sleep Time
Overall Period (Change From Baseline)
|
63.6 minutes
Standard Deviation 64.1
|
74.2 minutes
Standard Deviation 61.4
|
70.2 minutes
Standard Deviation 50.2
|
61.8 minutes
Standard Deviation 54.7
|
SECONDARY outcome
Timeframe: Baseline (screening period) and 4 weeks of treatmentPopulation: Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.
Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).
Outcome measures
| Measure |
Eszopiclone 1 mg- Elderly
n=80 Participants
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg- Elderly
n=83 Participants
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 2 mg- Non-elderly
n=84 Participants
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 Participants
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Total Number of Awakenings
Baseline
|
1.8 Number of Awakenings
Standard Deviation 0.9
|
1.9 Number of Awakenings
Standard Deviation 1.0
|
1.7 Number of Awakenings
Standard Deviation 0.9
|
1.6 Number of Awakenings
Standard Deviation 1.1
|
|
Mean Change From Baseline in Total Number of Awakenings
Overall Period (Change From Baseline)
|
-0.5 Number of Awakenings
Standard Deviation 0.7
|
-0.5 Number of Awakenings
Standard Deviation 0.8
|
-0.7 Number of Awakenings
Standard Deviation 0.9
|
-0.7 Number of Awakenings
Standard Deviation 0.9
|
Adverse Events
Eszopiclone 2 mg- Non-elderly
Eszopiclone 3 mg- Non-elderly
Eszopiclone 1 mg- Elderly
Eszopiclone 2 mg Elderly
Serious adverse events
| Measure |
Eszopiclone 2 mg- Non-elderly
n=84 participants at risk
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 participants at risk
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 1 mg- Elderly
n=81 participants at risk
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg Elderly
n=83 participants at risk
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
1.2%
1/84 • Number of events 1
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/84 • Number of events 1
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Musculoskeletal and connective tissue disorders
Clavicle fracture
|
0.00%
0/84
|
1.3%
1/77 • Number of events 1
|
0.00%
0/81
|
0.00%
0/83
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/84
|
1.3%
1/77 • Number of events 1
|
0.00%
0/81
|
0.00%
0/83
|
|
Endocrine disorders
Type 1 diabetes mellitus
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81 • Number of events 1
|
0.00%
0/83
|
|
Psychiatric disorders
Major depressive disorder
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81 • Number of events 1
|
0.00%
0/83
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81 • Number of events 1
|
0.00%
0/83
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81 • Number of events 1
|
0.00%
0/83
|
|
Vascular disorders
Oesophagitis haemorrhagic
|
0.00%
0/84
|
0.00%
0/77
|
0.00%
0/81
|
1.2%
1/83 • Number of events 1
|
|
Vascular disorders
Angina pectoris
|
0.00%
0/84
|
0.00%
0/77
|
0.00%
0/81
|
1.2%
1/83 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/84
|
0.00%
0/77
|
0.00%
0/81
|
1.2%
1/83 • Number of events 1
|
|
Injury, poisoning and procedural complications
Heat illness
|
1.2%
1/84 • Number of events 1
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
Other adverse events
| Measure |
Eszopiclone 2 mg- Non-elderly
n=84 participants at risk
Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 3 mg- Non-elderly
n=77 participants at risk
Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
Eszopiclone 1 mg- Elderly
n=81 participants at risk
Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
|
Eszopiclone 2 mg Elderly
n=83 participants at risk
Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.
|
|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
42.9%
36/84
|
57.1%
44/77
|
18.5%
15/81
|
27.7%
23/83
|
|
Infections and infestations
Nasopharyngitis
|
26.2%
22/84
|
18.2%
14/77
|
17.3%
14/81
|
21.7%
18/83
|
|
Nervous system disorders
Headache
|
3.6%
3/84
|
1.3%
1/77
|
4.9%
4/81
|
6.0%
5/83
|
|
Nervous system disorders
Somnolence
|
3.6%
3/84
|
7.8%
6/77
|
4.9%
4/81
|
2.4%
2/83
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
2/84
|
5.2%
4/77
|
4.9%
4/81
|
3.6%
3/83
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/84
|
1.3%
1/77
|
4.9%
4/81
|
3.6%
3/83
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
3/84
|
2.6%
2/77
|
4.9%
4/81
|
1.2%
1/83
|
|
General disorders
Thirst
|
2.4%
2/84
|
2.6%
2/77
|
3.7%
3/81
|
0.00%
0/83
|
|
Investigations
Glucose urine present
|
0.00%
0/84
|
0.00%
0/77
|
3.7%
3/81
|
2.4%
2/83
|
|
Nervous system disorders
Dizziness
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81
|
4.8%
4/83
|
|
Infections and infestations
Pharyngitis
|
3.6%
3/84
|
1.3%
1/77
|
1.2%
1/81
|
2.4%
2/83
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
2/84
|
1.3%
1/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
2/84
|
0.00%
0/77
|
0.00%
0/81
|
2.4%
2/83
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
2/84
|
1.3%
1/77
|
0.00%
0/81
|
3.6%
3/83
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/84
|
2.6%
2/77
|
3.7%
3/81
|
1.2%
1/83
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
0.00%
0/83
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/84
|
0.00%
0/77
|
0.00%
0/81
|
2.4%
2/83
|
|
Gastrointestinal disorders
Oral Discomfort
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
0.00%
0/83
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
0.00%
0/83
|
|
General disorders
Malaise
|
0.00%
0/84
|
2.6%
2/77
|
2.5%
2/81
|
1.2%
1/83
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
2.4%
2/84
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Infections and infestations
Bronchitis
|
2.4%
2/84
|
0.00%
0/77
|
2.5%
2/81
|
1.2%
1/83
|
|
Infections and infestations
Cystitis
|
0.00%
0/84
|
0.00%
0/77
|
3.7%
3/81
|
0.00%
0/83
|
|
Infections and infestations
Influenza
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
1.2%
1/83
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
2/84
|
0.00%
0/77
|
1.2%
1/81
|
2.4%
2/83
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81
|
2.4%
2/83
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81
|
2.4%
2/83
|
|
Investigations
Alanine Aminotransferase Increased
|
2.4%
2/84
|
1.3%
1/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/84
|
2.6%
2/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Investigations
Eosinophil Count Increased
|
2.4%
2/84
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Investigations
Gamma-glutamyltransferase Increased
|
2.4%
2/84
|
1.3%
1/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Investigations
White Blood Cell Count Increased
|
1.2%
1/84
|
2.6%
2/77
|
2.5%
2/81
|
1.2%
1/83
|
|
Investigations
Blood Urine Present
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
2.4%
2/83
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
2/84
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/84
|
0.00%
0/77
|
0.00%
0/81
|
2.4%
2/83
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
1.2%
1/83
|
|
Nervous system disorders
Sciatica
|
2.4%
2/84
|
0.00%
0/77
|
0.00%
0/81
|
0.00%
0/83
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
1.2%
1/83
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81
|
2.4%
2/83
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/84
|
0.00%
0/77
|
1.2%
1/81
|
2.4%
2/83
|
|
Vascular disorders
Hypertension
|
0.00%
0/84
|
0.00%
0/77
|
2.5%
2/81
|
2.4%
2/83
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place