Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Inclusion Criteria: * Diagnosis of primary fibromyalgia * 13-17 years of age * To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale * To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2) * To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2) * Unsatisfactory response to nonpharmacologic fibromyalgia treatment. Exclusion Criteria: * Severe psychiatric illness * Severe renal impairment * Evidence of active liver disease * Pregnant or breastfeeding * Significant risk of suicidality * Unable, unwilling or inadvisable to discontinue prohibited medications * History of alcohol abuse or drug abuse or dependence, within previous year * Current systemic infection * Autoimmune disease * History of seizure disorder (other than febrile seizures)