A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Viatris

Status and phase: Completed; Phase 3

Conditions: Transient Insomnia

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163046

A9451155

Details and patient eligibility

About

The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older with occasional sleeplessness in the month prior to screening

Exclusion criteria

• Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
• Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo