FMS European Long-Term Study

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia Syndrome

Treatments: Drug: milnacipran; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757731

F02207 GE 304

Details and patient eligibility

About

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

Enrollment: 490 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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490 participants in 3 patient groups

Minalcipran 100 mg

Experimental group

Treatment:

Drug: Placebo

Drug: milnacipran

Minalcipran 150 mg

Experimental group

Treatment:

Drug: Placebo

Drug: milnacipran

Minalcipran 200 mg

Experimental group

Treatment:

Drug: Placebo

Drug: milnacipran