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Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02040532
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : February 27, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Lee S. Cohen, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Vasomotor Disturbance Drug: Gabapentin Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-label gabapentin
Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Drug: 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.
Other Name: Neurontin




Primary Outcome Measures :
  1. 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. 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.

  2. 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

  3. 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 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.

  4. Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime [ Time Frame: 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.

  5. Severity of Insomnia [ Time Frame: 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.


  6. Sleep Quality and Disturbances Over Past Month [ Time Frame: 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.



Other Outcome Measures:
  1. Quality of Life-Overall [ Time Frame: Baseline, study completion at 7 weeks ]
    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.

  2. Quality of Life-Menopause Specific [ Time Frame: Baseline, study completion at 7 weeks ]

    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.




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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females aged 40-65 years
  2. Postmenopausal or perimenopausal
  3. Having bothersome hot flashes
  4. Having some bothersome hot flashes during the night
  5. Insomnia or problems sleeping
  6. In general, good health
  7. Signed informed consent

Exclusion Criteria:

  1. Recent use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD)
  2. Recent use of any prescribed therapy that is taken specifically for hot flashes
  3. Recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes
  4. Recent use of any prescribed medications with known hot flash efficacy
  5. Known hypersensitivity or contraindications (reasons not to take) to gabapentin
  6. Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
  7. Recent drug or alcohol abuse
  8. Lifetime diagnosis of psychosis or bipolar disorder
  9. Suicide attempt in the past 3 years or any current suicidal ideation
  10. Current major depression (assessed during screening)
  11. Pregnancy, intending pregnancy, or breast feeding
  12. History of:

    1. Renal insufficiency or a kidney disorder
    2. Sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy
  13. Any unstable medical condition
  14. Working a night/rotating shift
  15. Abnormal screening blood tests
  16. Current participation in another drug trial or intervention study
  17. Inability or unwillingness to complete the study procedures

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.gov identifier (NCT number): NCT02040532


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital

Publications:

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Responsible Party: Lee S. Cohen, MD, Director, Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02040532     History of Changes
Other Study ID Numbers: 2013P002196
5U01AG032700-05 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2014    Key Record Dates
Results First Posted: February 27, 2017
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents