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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436033
Recruitment Status : Completed
First Posted : February 16, 2007
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Pierre Fabre Medicament

Brief Summary:
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Drug: milnacipran Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1429 participants
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
Study Start Date : February 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: Minalcipran Drug: milnacipran

Primary Outcome Measures :
  1. 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 :
  1. comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria [ Time Frame: 12 weeks ]
  2. establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS). [ Time Frame: 19 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436033

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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
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Principal Investigator: Dr Jaime C BRANCO HOSPITAL EGAS MONIZ
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pierre Fabre Medicament Identifier: NCT00436033    
Other Study ID Numbers: F02207GE302
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs