Conditions: Fibromyalgia Sleep Disorders
Keywords: Fibromyalgia sleep maintenance disturbance pregabalin
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 119
Healthy volunteers: no

Brief summary:
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)

Detailed description:

Arms:
arm 1: flexible dosing Lyrica 300-450mg/day arm 2: Placebo

Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day intervention 2: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks

Protocol document: