Trial Outcomes & Findings for Treatment of Insomnia in Migraineurs (NCT NCT00812214)
NCT ID: NCT00812214
Last Updated: 2023-06-15
Results Overview
Participants were asked to record an estimated total time asleep on a daily basis. Nightly estimates were averaged over a 2 week period for baseline and 6 week period so that the total sleep time represents the average total time asleep each night.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
113 participants
Primary outcome timeframe
Baseline, 6 weeks
Results posted on
2023-06-15
Participant Flow
A total of 113 subjects were screened. 79 of them were randomized (69.9%). Of the 34 subjects who were not randomized, 8 were screen failures (23.5%), 17 were baseline failures (50.0%), 4 withdrew consent (11.8%), and 5 were lost to follow-up (14.7%).
Participant milestones
| Measure |
Eszopiclone 3 mg
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
41
|
|
Overall Study
COMPLETED
|
35
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Eszopiclone 3 mg
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
Baseline characteristics by cohort
| Measure |
Eszopiclone 3 mg
n=38 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=41 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=79 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=38 Participants
|
41 Participants
n=41 Participants
|
79 Participants
n=79 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=38 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=79 Participants
|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 11.1 • n=38 Participants
|
45.0 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
44.4 years
STANDARD_DEVIATION 10.8 • n=79 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=38 Participants
|
34 Participants
n=41 Participants
|
63 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=38 Participants
|
7 Participants
n=41 Participants
|
16 Participants
n=79 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
80 percentage of participants
n=35 Participants • Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
|
80 percentage of participants
n=40 Participants • Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
|
80 percentage of participants
n=75 Participants • Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
|
|
Race/Ethnicity, Customized
Other
|
20 percentage of participants
n=35 Participants • Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
|
20 percentage of participants
n=40 Participants • Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
|
20 percentage of participants
n=75 Participants • Baseline data only available for mITT participants (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache)
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
41 participants
n=41 Participants
|
79 participants
n=79 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: Modified ITT (defined as all participants who took study medication at least 5 days per week for the first 2 weeks of the 6-week treatment period and provided the corresponding diary entries for sleep and headache.)
Participants were asked to record an estimated total time asleep on a daily basis. Nightly estimates were averaged over a 2 week period for baseline and 6 week period so that the total sleep time represents the average total time asleep each night.
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Total Sleep Time
Baseline
|
5.4 hours
Standard Deviation 0.8
|
5.5 hours
Standard Deviation 1.0
|
|
Total Sleep Time
6 week average
|
6.3 hours
Standard Deviation 0.9
|
6.1 hours
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: modified ITT
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Nighttime Awakenings
Baseline
|
2.4 awakenings/night
Standard Deviation 1.5
|
2.7 awakenings/night
Standard Deviation 1.3
|
|
Nighttime Awakenings
6 weeks
|
1.5 awakenings/night
Standard Deviation 1.1
|
2.2 awakenings/night
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Measured every two weeks (1&2, 3&4, 5&6)Population: modified ITT
Participants were asked to keep a daily record. The average among weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6 were taken, resulting in 3 averages, where the lowest average is reported as the minimum value of the full range, the middle average is reported as the median, and the highest average is reported as the maximum value of the full range
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Nighttime Awakenings
|
1.5 awakenings/night
Interval 1.5 to 1.6
|
2.1 awakenings/night
Interval 2.1 to 2.2
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: modified ITT
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period * Overall sleep quality was measured on a scale of 1=poor to 10=excellent. * Daytime alertness was measured on a scale of 1=not alert to 10=extremely alert. * Daytime fatigue was measured on a scale of 1=not tired to 10=extremely tired. * Daytime functioning was measured on a scale of 1=poor to 10=excellent.
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Quality of Sleep
Overall sleep quality, Baseline
|
5.1 score on a scale
Standard Deviation 1.1
|
4.9 score on a scale
Standard Deviation 1.1
|
|
Quality of Sleep
Overall sleep quality, 6 weeks
|
6.7 score on a scale
Standard Deviation 1.2
|
6.2 score on a scale
Standard Deviation 1.0
|
|
Quality of Sleep
Daytime alertness, Baseline
|
6.1 score on a scale
Standard Deviation 1.1
|
6.0 score on a scale
Standard Deviation 1.4
|
|
Quality of Sleep
Daytime alertness, 6 weeks
|
6.9 score on a scale
Standard Deviation 1.3
|
6.6 score on a scale
Standard Deviation 1.2
|
|
Quality of Sleep
Daytime fatigue, Baseline
|
5.2 score on a scale
Standard Deviation 1.4
|
5.5 score on a scale
Standard Deviation 1.5
|
|
Quality of Sleep
Daytime fatigue, 6 weeks
|
4.3 score on a scale
Standard Deviation 1.4
|
5.0 score on a scale
Standard Deviation 1.5
|
|
Quality of Sleep
Daytime functioning, Baseline
|
6.5 score on a scale
Standard Deviation 1.2
|
6.3 score on a scale
Standard Deviation 1.5
|
|
Quality of Sleep
Daytime functioning, 6 weeks
|
7.0 score on a scale
Standard Deviation 1.3
|
6.9 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Measured every two weeks (1&2, 3&4, 5&6)Population: modified ITT
Participants were asked to keep a daily record. * Daytime fatigue was measured on a scale of 1=not tired to 10=extremely tired. The average among weeks 1 and 2, weeks 3 and 4, and weeks 5 and 6 were taken, resulting in 3 averages, where the lowest average is reported as the minimum value of the full range, the middle average is reported as the median, and the highest average is reported as the maximum value of the full range
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Daytime Fatigue
|
4.3 score on a scale
Interval 4.2 to 4.4
|
4.8 score on a scale
Interval 4.8 to 5.2
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: modified ITT
Number of days per week in which a participant had a headache. Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Headache Frequency
Baseline
|
2.9 days/week
Standard Deviation 1.2
|
3.1 days/week
Standard Deviation 1.2
|
|
Headache Frequency
6 weeks
|
2.5 days/week
Standard Deviation 1.3
|
2.5 days/week
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: modified ITT
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Headache Duration
Baseline
|
4.0 hours
Standard Deviation 2.3
|
3.7 hours
Standard Deviation 2.2
|
|
Headache Duration
6 weeks
|
3.9 hours
Standard Deviation 1.8
|
3.8 hours
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: modified ITT
Participants were asked to keep a daily record. 6 week data were averaged over the 6 week period * Headache intensity was measured on a scale of 1=not intense to 10=worst headache possible
Outcome measures
| Measure |
Eszoplicone 3mg
n=35 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
Placebo
n=40 Participants
Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.
|
|---|---|---|
|
Headache Intensity
Baseline
|
5.6 score on a scale
Standard Deviation 2.3
|
5.3 score on a scale
Standard Deviation 1.6
|
|
Headache Intensity
6 weeks
|
5.5 score on a scale
Standard Deviation 2.0
|
5.6 score on a scale
Standard Deviation 1.8
|
Adverse Events
Eszopiclone 3mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Egilius L.H. Spierings, M.D., Ph.D.
MedVadis Research Corporation
Phone: 617-744-1310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place