FMS European Long-Term Study

July 10, 2013 updated by: Pierre Fabre Medicament

A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Pardubice, Czech Republic, 530 02
        • Rheumatology Ambulance
  • Finland
      • Kuopio, Finland, 70100
        • Kuopion Oma Laakari Oy
  • France
      • Paris, France
        • Hôpital Hotel Dieu
  • Germany
      • Koln, Germany, D50931
        • KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
  • Italy
      • Milano, Italy, 20157
        • Ospedale Luigi Sacco
  • Norway
      • Lillehamer, Norway, 2609
        • Center for Clinical Studies
  • Portugal
      • Lisboa, Portugal, 1349-019
        • Hospital Egas Moniz
  • Romania
      • Bucharest, Romania, 020475
        • Dr I Cantacuzino Clinical Hospital
  • Spain
      • Barcelona, Spain, 08024
        • Hospital de la Esperanza
  • Sweden
      • Molndal, Sweden, 43137
        • Gottfriesclinic Ab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

  • Principal Investigator: Jaime C BRANCO, MD, HOSPITAL EGAS MONIZ, Lisboa, Portugal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F02207 GE 304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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