A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Viatris

Status and phase: Completed; Phase 3

Conditions: Transient Insomnia

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674752

A9451157

Details and patient eligibility

About

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

Enrollment: 377 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
• Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening

Exclusion criteria

• Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
• Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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377 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

B

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

C

Placebo Comparator group

Treatment:

Drug: Placebo