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A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Medicament Identifier:
First received: February 15, 2007
Last updated: July 10, 2013
Last verified: July 2013
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria [ Time Frame: 12 weeks ]
  • establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS). [ Time Frame: 19 weeks ]

Enrollment: 1429
Study Start Date: February 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Minalcipran Drug: milnacipran


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

  • psychiatric illness
  • depression of generalised anxiety disorder
  • suicidal risk
  • substance abuse
  • active cardiac disease
  • pulmonary dysfunction
  • liver disease
  • renal impairment
  • autoimmune disease
  • chronic inflammatory rheumatoid disease
  • current systemic infection
  • epileptic
  • active cancer
  • sleep apnea
  • active peptic ulcer
  • inflammatory bowel disease
  • unstable endocrine disease
  • for men : prostatic enlargement of genito-urinary disorders
  • for women : pregnancy or breast feeding
  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: NCT00436033

Czech Republic
Rheumatology Ambulance
Pardubice, Czech Republic, 530 02
FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
Frederiksberg, Denmark, F2000
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
"Nasz Lekarz"
Torun, Poland
Hospital Egas Moniz
Lisboa, Portugal, 1349-019
Bucharest, Romania, 020475
Hospital de La Esperanza
Barcelona, Spain, 08024
Gottfriesclinic Ab
Molndal, Sweden, 43137
United Kingdom
KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology
London, United Kingdom, SE59RJ
Sponsors and Collaborators
Pierre Fabre Medicament
Principal Investigator: Dr Jaime C BRANCO HOSPITAL EGAS MONIZ
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pierre Fabre Medicament Identifier: NCT00436033     History of Changes
Other Study ID Numbers: F02207GE302
Study First Received: February 15, 2007
Last Updated: July 10, 2013

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents processed this record on September 21, 2017