FMS European Long-Term Study

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Medicament Identifier:
First received: September 22, 2008
Last updated: July 10, 2013
Last verified: July 2013
Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

Condition Intervention Phase
Fibromyalgia Syndrome
Drug: milnacipran
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 490
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minalcipran 100 mg Drug: milnacipran
hard capsule
Drug: Placebo
hard capsule
Experimental: Minalcipran 150 mg Drug: milnacipran
hard capsule
Drug: Placebo
hard capsule
Experimental: Minalcipran 200 mg Drug: milnacipran
hard capsule
Drug: Placebo
hard capsule


Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00757731

Czech Republic
Rheumatology Ambulance
Pardubice, Czech Republic, 530 02
Kuopion Oma Laakari Oy
Kuopio, Finland, 70100
Hopital Hotel Dieu
Paris, France
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Koln, Germany, D50931
Ospedale Luigi Sacco
Milano, Italy, 20157
Center For Clinical Studies
Lillehamer, Norway, 2609
Hospital Egas Moniz
Lisboa, Portugal, 1349-019
Bucharest, Romania, 020475
Hospital de La Esperanza
Barcelona, Spain, 08024
Gottfriesclinic Ab
Molndal, Sweden, 43137
Sponsors and Collaborators
Pierre Fabre Medicament
Principal Investigator: Jaime C BRANCO, MD HOSPITAL EGAS MONIZ, Lisboa, Portugal
  More Information

No publications provided by Pierre Fabre Medicament

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pierre Fabre Medicament Identifier: NCT00757731     History of Changes
Other Study ID Numbers: F02207 GE 304 
Study First Received: September 22, 2008
Last Updated: July 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on February 04, 2016