Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms in Peri- and Postmenopausal Women | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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	Menopause Hot Flashes Vasomotor Disturbance
Intervention	Drug: Gabapentin
Phase	N/A
Sponsor	Massachusetts General Hospital
Responsible Party	Massachusetts General Hospital
ClinicalTrials.gov Identifier	NCT02040532
First Received	January 16, 2014
Last Updated	April 25, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	January 16, 2014
Last Updated Date	April 25, 2014
Start Date	January 2014
Estimated Primary Completion Date	March 2015
Current Primary Outcome Measures	Tolerability of gabapentin [Time Frame: 7 weeks] [Designated as safety issue: No]Measured by self-report responses to questionnaires VMS frequency, severity, and bothersomeness [Time Frame: 7 weeks] [Designated as safety issue: No]Measured by self-report VMS diaries twice daily. Subjective sleep quality [Time Frame: 7 weeks] [Designated as safety issue: No]Measured by self-report responses to questionnaires at week 4 and week 7, and daily self-report sleep diary.
Current Secondary Outcome Measures	Anxiety [Time Frame: 7 weeks] [Designated as safety issue: No]Measured by self-report responses to questionnaires Depressed mood [Time Frame: 7 weeks] [Designated as safety issue: No]Measured by self-report responses to questionnaires

Descriptive Information[ + expand ][ + ]

Brief Title	Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms in Peri- and Postmenopausal Women
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 in Peri- and Postmenopausal Women With Vasomotor Symptoms
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.
Detailed Description	Twenty-five peri- and postmenopausal women at the Boston sites (MGH and BWH) will be enrolled into this open-label pilot study. This will be 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 will follow 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) will be assessed systematically at each study visit. The dose titration schedule will be followed in all participants unless there are dose-limiting toxicities.
Study Type	Interventional
Study Phase	N/A
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Menopause Hot Flashes Vasomotor Disturbance
Intervention	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 Names: Neurontin
Study Arm (s)	Experimental: Open-label gabapentin Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	25
Estimated Completion Date	March 2015
Estimated Primary Completion Date	March 2015
Eligibility 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
Gender	Female
Ages	40 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Abigail Davies 617-724-6540 adavies2@partners.org
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02040532
Other Study ID Numbers	2013P002196
Has Data Monitoring Committee	No
Information Provided By	Massachusetts General Hospital
Study Sponsor	Massachusetts General Hospital
Collaborators	Brigham and Women's Hospital National Institute on Aging (NIA)
Investigators	Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
Verification Date	April 2014

Locations[ + expand ][ + ]

Massachusetts General Hospital	Boston, Massachusetts, United States, 02114 Contact: Abigail Davies \| 617-724-6540 \| adavies2@partners.org Principal Investigator: Lee S Cohen, MD Recruiting
Brigham and Women's Hospital	Boston, Massachusetts, United States, 02116 Contact: Semmie Kim \| 617-525-6459 \| skim69@partners.org Principal Investigator: Hadine Joffe, MD, MSc Recruiting