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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01AG032700-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| National Institute on Aging (NIA) | NIH |
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The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. We hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.
Thirty-two peri- and postmenopausal women at the Boston sites (MGH and BWH) were enrolled into this open-label pilot study. The study was 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. The intervention study followed a 3-week screening period to establish a stable baseline for insomnia symptoms and VMS and to determine the safety of administering gabapentin in study participants. Tolerability and treatment response (insomnia symptoms, nighttime VMS) were assessed systematically at each study visit. The dose titration schedule was followed in all participants unless there are dose-limiting toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label gabapentin | Experimental | Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Gabapentin | 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. | Baseline, Week 4 visit, and study completion at 7 weeks |
| Reason for Non-tolerability and Discontinuation of Gabapentin | Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion | Baseline, Week 4 Visit, and study completion at 7 weeks |
| Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime | 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. | Baseline, study completion at 7 weeks |
| Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life-Overall | 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. |
Inclusion Criteria:
Exclusion Criteria:
Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)
Recent use of any prescribed therapy that is taken specifically for hot flashes
Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes
Recent use of any prescribed medications with known hot flash efficacy
Known hypersensitivity or contraindications (reasons not to take) to gabapentin
Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
Recent drug or alcohol abuse
Lifetime diagnosis of psychosis or bipolar disorder
Suicide attempt in the past 3 years or any current suicidal ideation
Current major depression (assessed during screening)
Pregnancy, intending pregnancy, or breast feeding
History of:
Any unstable medical condition
Working a night/rotating shift
Abnormal screening blood tests
Current participation in another drug trial or intervention study
Inability or unwillingness to complete the study procedures
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| Name | Affiliation | Role |
|---|---|---|
| Lee S Cohen, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22433978 | Background | Ensrud KE, Joffe H, Guthrie KA, Larson JC, Reed SD, Newton KM, Sternfeld B, Lacroix AZ, Landis CA, Woods NF, Freeman EW. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. Menopause. 2012 Aug;19(8):848-55. doi: 10.1097/gme.0b013e3182476099. | |
| 20035910 | Background | Joffe H, Petrillo L, Viguera A, Koukopoulos A, Silver-Heilman K, Farrell A, Yu G, Silver M, Cohen LS. Eszopiclone improves insomnia and depressive and anxious symptoms in perimenopausal and postmenopausal women with hot flashes: a randomized, double-blinded, placebo-controlled crossover trial. Am J Obstet Gynecol. 2010 Feb;202(2):171.e1-171.e11. doi: 10.1016/j.ajog.2009.10.868. Epub 2009 Dec 24. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerability of Gabapentin | 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. | All 26 participants who initiated treatment with gabapentin were included in this analysis. | Posted | Count of Participants | Participants | Baseline, Week 4 visit, and study completion at 7 weeks |
|
Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Nervous system disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Cohen | MGH Center for Women's Mental Health | 617-724-0816 | lcohen2@partners.org |
Not provided
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
| Baseline, study completion at 7 weeks |
| Severity of Insomnia | 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. | Baseline, study completion at 7 weeks |
| Sleep Quality and Disturbances Over Past Month | 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. | Baseline, study completion at 7 weeks |
| Baseline, study completion at 7 weeks |
| Quality of Life-Menopause Specific | 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. | Baseline, study completion at 7 weeks |
| Boston |
| Massachusetts |
| 02116 |
| United States |
| 17138773 | Background | Soares CN, Joffe H, Rubens R, Caron J, Roth T, Cohen L. Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1402-10. doi: 10.1097/01.AOG.0000245449.97365.97. |
| 19708803 | Background | Yurcheshen ME, Guttuso T Jr, McDermott M, Holloway RG, Perlis M. Effects of gabapentin on sleep in menopausal women with hot flashes as measured by a Pittsburgh Sleep Quality Index factor scoring model. J Womens Health (Larchmt). 2009 Sep;18(9):1355-60. doi: 10.1089/jwh.2008.1257. |
| 17917611 | Background | Butt DA, Lock M, Lewis JE, Ross S, Moineddin R. Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial. Menopause. 2008 Mar-Apr;15(2):310-8. doi: 10.1097/gme.0b013e3180dca175. |
| 16139656 | Background | Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. doi: 10.1016/S0140-6736(05)67215-7. |
| 16816054 | Background | Reddy SY, Warner H, Guttuso T Jr, Messing S, DiGrazio W, Thornburg L, Guzick DS. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):41-8. doi: 10.1097/01.AOG.0000222383.43913.ed. |
| 20050764 | Background | Aguirre W, Chedraui P, Mendoza J, Ruilova I. Gabapentin vs. low-dose transdermal estradiol for treating post-menopausal women with moderate to very severe hot flushes. Gynecol Endocrinol. 2010 May;26(5):333-7. doi: 10.3109/09513590903511539. |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Gynecological History | Count of Participants | Participants |
|
| Years since last menstrual period (LMP) | Count of Participants | Participants |
|
| Number of Children | Count of Participants | Participants |
|
| Smoking History | Count of Participants | Participants |
|
| Baseline BMI | Mean | Standard Deviation | kg/m^2 |
|
| Provider Status | Count of Participants | Participants |
|
|
|
| Primary | Reason for Non-tolerability and Discontinuation of Gabapentin | Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion | Four subjects initiated treatment with gabapentin but discontinued prior to study completion due to side effects. | Posted | Count of Participants | Participants | Baseline, Week 4 Visit, and study completion at 7 weeks |
|
|
|
| Primary | Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime | 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. | 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. | Posted | Mean | Full Range | vasomotor symptoms (VMS) per day | Baseline, study completion at 7 weeks |
|
|
|
| Primary | Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime | 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. | 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. | Posted | Mean | Full Range | vasomotor symptoms (VMS) per night | Baseline, study completion at 7 weeks |
|
|
|
| Primary | Severity of Insomnia | 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. | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had ISI data at baseline and study completion. | Posted | Mean | Full Range | scores on a scale | Baseline, study completion at 7 weeks |
|
|
|
| Primary | Sleep Quality and Disturbances Over Past Month | 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. | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had PSQI data at baseline and study completion. | Posted | Mean | Full Range | scores on a scale | Baseline, study completion at 7 weeks |
|
|
|
| Other Pre-specified | Quality of Life-Overall | 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. | 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. | Posted | Mean | Full Range | scores on a scale | Baseline, study completion at 7 weeks |
|
|
|
| Other Pre-specified | Quality of Life-Menopause Specific | 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. | Analyzable population includes all 20 completers of the study, since all 20 completers of the study had MENQOL data at baseline and study completion. | Posted | Mean | Full Range | scores on a scale | Baseline, study completion at 7 weeks |
|
|
|
| 0 |
| 26 |
| 11 |
| 26 |
| Sweating | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hot flashes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Feeling tired/fatigue | General disorders | Systematic Assessment |
|
| Feeling drowsy during the day | General disorders | Systematic Assessment |
|
| Problems falling asleep | General disorders | Systematic Assessment |
|
| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Stomach/abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Gas | Gastrointestinal disorders | Systematic Assessment |
|
| Tension | Psychiatric disorders | Systematic Assessment |
|
| Increased interest in sex | Reproductive system and breast disorders | Systematic Assessment |
|
| Waking up too early | General disorders | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Aches, pains in muscles, bones or joints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Mild rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |