FMS European Long-Term Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT00757731
First received: September 22, 2008
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Pierre Fabre Medicament

Additional 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
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:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on April 14, 2014