FMS European Long-Term Study

Pierre Fabre Medicament490 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

490

Conditions

Fibromyalgia Syndrome

Interventions

milnacipranDRUG

hard capsule

PlaceboDRUG

hard capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 71 Years

Medical Language ↔ Plain English

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

Locations (10)

Rheumatology Ambulance

Pardubice, Czechia

Kuopion Oma Laakari Oy

Kuopio, Finland

Hopital Hotel Dieu

Paris, France

KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care

Cologne, Germany

Outcomes

Primary Outcomes

To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily

Time frame: 12 months

Secondary Outcomes

To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily

Time frame: 12 months

Data from ClinicalTrials.gov

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