A Polysomnographic Study of Single-Dose 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

NCT00666770

A9451139

Details and patient eligibility

About

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >/= 18 years
• 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)
• Recreational drug use within past 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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309 participants in 3 patient groups, including a placebo group

Gabapentin 250 mg

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Gabapentin 500 mg

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo