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FMS European Long-Term Study

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ClinicalTrials.gov Identifier: NCT00757731
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 490 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, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Study Start Date : September 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00757731


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT00757731     History of Changes
Other Study ID Numbers: F02207 GE 304
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
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