Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Sleep Disorders; Fibromyalgia

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883740

A0081165

Details and patient eligibility

About

The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must meet diagnostic criteria for fibromyalgia;
• Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.

Exclusion criteria

• History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
• Use of medications known to affect sleep wake function by Visit 2;
• Involved in night or rotating shift work, or travel across >4 time zones 14 days prior to screening and during study; regular daytime napping
• PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on either night of PSG.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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119 participants in 2 patient groups, including a placebo group

Lyrica

Experimental group

Description:

flexible dosing Lyrica 300-450mg/day

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo