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Completed

NCT Number: NCT00757731

FMS European Long-Term Study

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

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rheumatology Ambulance, Pardubice, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milnacipran

Drug

hard capsule

Placebo

Drug

hard capsule

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2008
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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