FMS European Long-Term Study

A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

Inclusion Criteria:

• patient who completed the 3-month F02207 GE 302 study
• patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

Exclusion Criteria:

• known hypersensitivity to milnacipran
• major depressive episode
• significant risk of suicide
• generalised anxiety disorder
• substance abuse
• clinically significant cardiac disease
• pulmonary dysfunction
• active liver disease
• renal impairment
• autoimmune disease
• current systemic infection
• epileptic
• active cancer
• severe sleep apnoea
• active peptic ulcer
• inflammatory bowel disease
• unstable endocrine disease
• (for men) prostatic enlargement or other genito-urinary disorders
• (for women) pregnancy or breastfeeding