FMS European Long-Term Study

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Levomilnacipran; Milnacipran

Criteria

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