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FMS European Long-Term Study

Primary Purpose

Fibromyalgia Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
milnacipran
Placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology Ambulance
  • Kuopion Oma Laakari Oy
  • Hopital Hotel Dieu
  • KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
  • Ospedale Luigi Sacco
  • Center For Clinical Studies
  • Hospital Egas Moniz
  • Dr I CANTACUZINO CLINICAL HOSPITAL
  • Hospital de La Esperanza
  • Gottfriesclinic Ab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Minalcipran 100 mg

Minalcipran 150 mg

Minalcipran 200 mg

Arm Description

Outcomes

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

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

Full Information

First Posted
September 22, 2008
Last Updated
July 10, 2013
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT00757731
Brief Title
FMS European Long-Term Study
Official Title
A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minalcipran 100 mg
Arm Type
Experimental
Arm Title
Minalcipran 150 mg
Arm Type
Experimental
Arm Title
Minalcipran 200 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
milnacipran
Intervention Description
hard capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
hard capsule
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime C BRANCO, MD
Organizational Affiliation
HOSPITAL EGAS MONIZ, Lisboa, Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Ambulance
City
Pardubice
ZIP/Postal Code
530 02
Country
Czech Republic
Facility Name
Kuopion Oma Laakari Oy
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Hopital Hotel Dieu
City
Paris
Country
France
Facility Name
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
City
Koln
ZIP/Postal Code
D50931
Country
Germany
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Center For Clinical Studies
City
Lillehamer
ZIP/Postal Code
2609
Country
Norway
Facility Name
Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Dr I CANTACUZINO CLINICAL HOSPITAL
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Hospital de La Esperanza
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Gottfriesclinic Ab
City
Molndal
ZIP/Postal Code
43137
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21459941
Citation
Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.
Results Reference
derived

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FMS European Long-Term Study

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