Trial Outcomes & Findings for Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women (NCT NCT02040532)
NCT ID: NCT02040532
Last Updated: 2019-08-07
Results Overview
Tolerability of gabapentin was assessed by self-report at the week 1, week 4 and week 7 contacts by asking participants to complete the SAFTEE-SI and CPFQ questionnaires and prompting subjects to report any adverse events at each study visit. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from 300-mg to 600-mg and to remain on the higher dose for the duration of the trial.
COMPLETED
NA
32 participants
Baseline, Week 4 visit, and study completion at 7 weeks
2019-08-07
Participant Flow
Women were recruited from the Boston area and enrolled at either the Massachusetts General Hospital Center for Women's Mental Health or the Brigham and Women's Hospital Women's Hormones and Aging Research Program.
Participant milestones
| Measure |
Open-label Gabapentin
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Received at Least One Dose of Medication
|
26
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Open-label Gabapentin
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Open-label Gabapentin
n=26 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
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|---|---|
|
Age, Continuous
|
55.31 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
|
Highest Level of Education
Less than College Graduate
|
18 Participants
n=5 Participants
|
|
Highest Level of Education
College Graduate/Baccalaureate Degree
|
4 Participants
n=5 Participants
|
|
Highest Level of Education
Graduate Degree
|
4 Participants
n=5 Participants
|
|
Employment
Employed Full-Time
|
8 Participants
n=5 Participants
|
|
Employment
Employed Part-Time
|
6 Participants
n=5 Participants
|
|
Employment
Retired or Unemployed
|
8 Participants
n=5 Participants
|
|
Employment
Disabled, Unable to work, on Medical Leave
|
4 Participants
n=5 Participants
|
|
Marital Status
Never Married
|
7 Participants
n=5 Participants
|
|
Marital Status
Divorced or Separated
|
5 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=5 Participants
|
|
Marital Status
Presently Married or Living with Partner
|
12 Participants
n=5 Participants
|
|
Gynecological History
Perimenopausal
|
5 Participants
n=5 Participants
|
|
Gynecological History
Naturally Postmenopausal
|
18 Participants
n=5 Participants
|
|
Gynecological History
Surgically Postmenopausal
|
3 Participants
n=5 Participants
|
|
Years since last menstrual period (LMP)
<1 Years
|
5 Participants
n=5 Participants
|
|
Years since last menstrual period (LMP)
1-5 Years
|
13 Participants
n=5 Participants
|
|
Years since last menstrual period (LMP)
>5 Years
|
8 Participants
n=5 Participants
|
|
Number of Children
No Children
|
12 Participants
n=5 Participants
|
|
Number of Children
1 to 4 Children
|
14 Participants
n=5 Participants
|
|
Smoking History
Current Smoker
|
4 Participants
n=5 Participants
|
|
Smoking History
Non-Current Smoker
|
22 Participants
n=5 Participants
|
|
Baseline BMI
|
29.4 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Provider Status
Has Doctor/Nurse Providing Regular Care
|
25 Participants
n=5 Participants
|
|
Provider Status
Does not have Doctor/Nurse Providing Regular Care
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4 visit, and study completion at 7 weeksPopulation: All 26 participants who initiated treatment with gabapentin were included in this analysis.
Tolerability of gabapentin was assessed by self-report at the week 1, week 4 and week 7 contacts by asking participants to complete the SAFTEE-SI and CPFQ questionnaires and prompting subjects to report any adverse events at each study visit. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from 300-mg to 600-mg and to remain on the higher dose for the duration of the trial.
Outcome measures
| Measure |
Open-label Gabapentin
n=26 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Tolerability of Gabapentin
# of subjects who tolerated gabapentin
|
22 Participants
|
|
Tolerability of Gabapentin
# of subjects who did not tolerate gabapentin
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4 Visit, and study completion at 7 weeksPopulation: Four subjects initiated treatment with gabapentin but discontinued prior to study completion due to side effects.
Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion
Outcome measures
| Measure |
Open-label Gabapentin
n=4 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Reason for Non-tolerability and Discontinuation of Gabapentin
Morning sickness and Nausea
|
3 Participants
|
|
Reason for Non-tolerability and Discontinuation of Gabapentin
Mild Rash
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, study completion at 7 weeksPopulation: Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.
Outcome measures
| Measure |
Open-label Gabapentin
n=19 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime
mean VMS per day at baseline
|
4.1 vasomotor symptoms (VMS) per day
Interval 0.2 to 8.5
|
|
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime
mean VMS per day at study completion
|
2.2 vasomotor symptoms (VMS) per day
Interval 0.0 to 6.7
|
PRIMARY outcome
Timeframe: Baseline, study completion at 7 weeksPopulation: Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.
Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.
Outcome measures
| Measure |
Open-label Gabapentin
n=19 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime
mean VMS per night at baseline
|
3.5 vasomotor symptoms (VMS) per night
Interval 1.5 to 8.0
|
|
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime
mean VMS per night at study completion
|
1.1 vasomotor symptoms (VMS) per night
Interval 0.0 to 3.9
|
PRIMARY outcome
Timeframe: Baseline, study completion at 7 weeksPopulation: Analyzable population includes all 20 completers of the study, since all 20 completers of the study had ISI data at baseline and study completion.
Severity of insomnia was measured throughout the study using the Insomnia Severity Index (ISI) .The ISI is a 7-item scale that evaluates the severity of insomnia retrospectively over the past week. The scale is more specific to insomnia symptoms than the Pittsburgh scale (PSQI), which focuses more broadly on overall sleep quality. The ISI score ranges from a minimum of 0 to 28. A score of 0-7=no clinically significant insomnia, 8-14=subthreshold insomnia, 5-21=clinical insomnia (moderate severity), 22-28=clinical insomnia (severe), with higher values indicating more severe insomnia.
Outcome measures
| Measure |
Open-label Gabapentin
n=20 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Severity of Insomnia
mean ISI score at baseline
|
15.6 scores on a scale
Interval 8.0 to 24.0
|
|
Severity of Insomnia
mean ISI score at study completion
|
6.0 scores on a scale
Interval 0.0 to 18.0
|
PRIMARY outcome
Timeframe: Baseline, study completion at 7 weeksPopulation: Analyzable population includes all 20 completers of the study, since all 20 completers of the study had PSQI data at baseline and study completion.
Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Open-label Gabapentin
n=20 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Sleep Quality and Disturbances Over Past Month
PSQI total score at baseline
|
9.6 scores on a scale
Interval 4.0 to 17.0
|
|
Sleep Quality and Disturbances Over Past Month
PSQI total score at study completion
|
4.9 scores on a scale
Interval 0.0 to 12.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, study completion at 7 weeksPopulation: Analyzable population includes all 20 completers of the study, since all 20 completers of the study had Q-LES-Q data at baseline and study completion.
Quality of life-Overall was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16-item self-report questionnaire that assesses enjoyment of and satisfaction with life. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70 with higher scores indicating higher quality of life enjoyment and satisfaction.
Outcome measures
| Measure |
Open-label Gabapentin
n=20 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Quality of Life-Overall
Q-LES-Q scores at baseline
|
60.3 scores on a scale
Interval 30.0 to 80.0
|
|
Quality of Life-Overall
Q-LES-Q scores at study completion
|
61.7 scores on a scale
Interval 35.0 to 80.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, study completion at 7 weeksPopulation: Analyzable population includes all 20 completers of the study, since all 20 completers of the study had MENQOL data at baseline and study completion.
The Quality of life-Menopause specific is assessed by the Menopause Specific Quality of Life (MENQOL). The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8.
Outcome measures
| Measure |
Open-label Gabapentin
n=20 Participants
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Quality of Life-Menopause Specific
MENQOL scores at baseline
|
3.2 scores on a scale
Interval 1.0 to 5.0
|
|
Quality of Life-Menopause Specific
MENQOL scores at study completion
|
1.9 scores on a scale
Interval 1.0 to 3.5
|
Adverse Events
Open-label Gabapentin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label Gabapentin
n=26 participants at risk
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
|
|---|---|
|
Nervous system disorders
Headaches
|
34.6%
9/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Sweating
|
30.8%
8/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Pregnancy, puerperium and perinatal conditions
Hot flashes
|
26.9%
7/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
23.1%
6/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
General disorders
Feeling tired/fatigue
|
23.1%
6/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
General disorders
Feeling drowsy during the day
|
30.8%
8/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
General disorders
Problems falling asleep
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Metabolism and nutrition disorders
Weight gain
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Gastrointestinal disorders
Stomach/abdominal discomfort
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Gastrointestinal disorders
Gas
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Psychiatric disorders
Tension
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Reproductive system and breast disorders
Increased interest in sex
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
General disorders
Waking up too early
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Musculoskeletal and connective tissue disorders
Aches, pains in muscles, bones or joints
|
15.4%
4/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
General disorders
Nausea
|
11.5%
3/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
|
Skin and subcutaneous tissue disorders
Mild rash
|
3.8%
1/26 • Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place