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NCT02040532 · ClinicalTrials.gov registry record · NA
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT02040532: Completed NA study, sponsored by Massachusetts General Hospital.
NCT02040532 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02040532, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT02040532 record still lists
NCT02040532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Gabapentin is the first listed.
NCT02040532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02040532 about?
NCT02040532 is a clinical study titled "Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women". 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 postmeno...
What is the current status of trial NCT02040532?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2014-01. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02040532?
The interventions under investigation include: Gabapentin (DRUG).
Who is sponsoring clinical trial NCT02040532?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02040532's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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