A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance

Viatris

Status and phase: Completed; Phase 3

Conditions: Transient Insomnia

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666939

A9451141

Details and patient eligibility

About

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.

Enrollment: 773 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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773 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