Pilot Study to Assess Tolerability and Preliminary Efficacy of a Titrated Dose of Gabapentin up to 600mg Administered at Bedtime for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women With VMS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 40-65 years
- •Postmenopausal or perimenopausal
- •Having bothersome hot flashes
- •Having some bothersome hot flashes during the night
- •Insomnia or problems sleeping
- •In general, good health
- •Signed informed consent
排除标准
- •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:
- •Renal insufficiency or a kidney disorder
- •Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy
- •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
研究组 & 干预措施
Open-label gabapentin
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime
时间窗: Baseline, study completion at 7 weeks
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.
Severity of Insomnia
时间窗: Baseline, study completion at 7 weeks
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.
Tolerability of Gabapentin
时间窗: 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. 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.
Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime
时间窗: Baseline, study completion at 7 weeks
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.
Reason for Non-tolerability and Discontinuation of Gabapentin
时间窗: Baseline, Week 4 Visit, and study completion at 7 weeks
Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion
Sleep Quality and Disturbances Over Past Month
时间窗: Baseline, study completion at 7 weeks
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.
次要结局
未报告次要终点
研究者
Lee S. Cohen, MD
Director, Center for Women's Mental Health
Massachusetts General Hospital