The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
784
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Matched placebo 30 minutes prior to bedtime
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Boise, Idaho, United States
Subjective sleep latency
Time frame: Hour +8
Subjective assessment of sleep refreshment
Time frame: Hour +8
Subjective assessment of sleep quality
Time frame: Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Time frame: Hour +8
KSD individual scores
Time frame: Hour +8
Digit Symbol Substitution Test
Time frame: Hour +8
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
Time frame: Hour +8
Stanford Sleepiness Scale
Time frame: Hour +13
Vital signs
Time frame: Hour +8
Adverse events
Time frame: Hour +13
Subjective number of awakenings
Time frame: Hour +8
Subjective wake after sleep onset
Time frame: Hour +8
Subjective total sleep time
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Pfizer Investigational Site
Mount Laurel, New Jersey, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Spartanburg, South Carolina, United States
Pfizer Investigational Site
Dallas, Texas, United States
Time frame: Hour +8