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Study record managers: refer to the Data Element Definitions if submitting registration or information. Drug: Gabapentin The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from mg for one week, followed by mg for 3 weeks, and then mg for 3 weeks. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from mg to mg and to remain on the higher dose for the duration of the trial. Reason for Non-tolerability and Discontinuation of Gabapentin [ Time Frame: Baseline, Week 4 Visit, and study completion at 7 weeks ] Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion Vasomotor Symptoms VMS Frequency, Severity, and Bothersomeness During Daytime [ Time Frame: Baseline, study completion at 7 weeks ] Vasomotor symptoms VMS were tracked and quantified prospectively using a daily hot flash diary.
The diary asks for the subject to log 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 HFRDISa item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.
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 PSQIwhich focuses more broadly on overall sleep quality. The ISI score ranges from a minimum of 0 to 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 Higher scores indicate worse sleep quality.
Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor itemspsychosocial itemsphysical itemsand sexual items 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 of items within that domain. Non-endorsement of an item is scored a "1" and endorsement a "2," plus the of the particular rating, so that the possible score on any item ranges from Total score also ranges from Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details.
First Posted : February 27, Last Update Posted : August 7, Study Description. 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 Gabapentin for insomnia dosage the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.
Detailed Description:. The study was a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from mg for one week, followed by mg for 3 weeks, and then mg for 3 weeks. The intervention study followed a 3-week Gabapentin for insomnia dosage 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. FDA Resources. Arms and Interventions. The study is a 7-week intervention study using open-label gabapentin at bedtime Gabapentin for insomnia dosage a scheduled dose titration from mg for one week, followed by mg for 3 weeks, and then mg for 3 Gabapentin for insomnia dosage.
Outcome Measures. Primary Outcome Measures : Tolerability of Gabapentin [ Time Frame: Baseline, Week 4 visit, and study completion at 7 weeks ] 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.
Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion. Vasomotor symptoms VMS were tracked and quantified prospectively using a daily hot flash diary. The Q-LES-Q is a item self-report questionnaire that assesses enjoyment of and satisfaction with life. The last two items are not included in the Gabapentin for insomnia dosage 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.
Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. 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. Epub Dec Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a Gabapentin for insomnia dosage controlled trial. Obstet Gynecol. 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. Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial.
Gabapentin for hot flashes in women with breast cancer: a randomised double-blind placebo-controlled trial. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Gabapentin vs. Gynecol Endocrinol. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Menopause Hot Flashes Vasomotor Disturbance. Drug: Gabapentin. Not Applicable. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Experimental: Open-label gabapentin Dose titration of mg for 1 week, mg for 3 weeks, and mg for 3 weeks. Other Name: Neurontin. Lee S. January 20, Key Record Dates.Gabapentin for insomnia dosage
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