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CompletedNCT00757731Updated Jul 11, 2013

FMS European Long-Term Study

A Phase 3 interventional study of milnacipran and Placebo in Fibromyalgia Syndrome, sponsored by Pierre Fabre Medicament. Completed at 10 sites in 10 countries. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2013-07-11.

Sponsored by Pierre Fabre Medicament · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
490
Allocation
Randomized
Ages
18 Years to 71 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Fibromyalgia Syndrome
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 490 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 71 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
490 participants (actual)

Study arms

  • Experimental
    Minalcipran 100 mg

    Drug: milnacipran · Drug: Placebo

  • Experimental
    Minalcipran 150 mg

    Drug: milnacipran · Drug: Placebo

  • Experimental
    Minalcipran 200 mg

    Drug: milnacipran · Drug: Placebo

Interventions

  • Drugmilnacipran

    hard capsule

  • DrugPlacebo

    hard capsule

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

10 sites
  • Rheumatology Ambulance
    Pardubice, 530 02, Czech Republic
  • Kuopion Oma Laakari Oy
    Kuopio, 70100, Finland
  • Hopital Hotel Dieu
    Paris, France
  • KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
    Koln, D50931, Germany
  • Ospedale Luigi Sacco
    Milano, 20157, Italy
  • Center For Clinical Studies
    Lillehamer, 2609, Norway
  • Hospital Egas Moniz
    Lisboa, 1349-019, Portugal
  • Dr I CANTACUZINO CLINICAL HOSPITAL
    Bucharest, 020475, Romania
  • Hospital de La Esperanza
    Barcelona, 08024, Spain
  • Gottfriesclinic Ab
    Molndal, 43137, Sweden
08

References and documents

Publications

  • 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. PubMed 21459941 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00757731
Lead sponsor
Pierre Fabre Medicament
Responsible party
Sponsor
First posted
Sep 23, 2008
Start date
Sep 2006
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Jul 11, 2013

Study contacts

Jaime C BRANCO, MD
principal investigator · HOSPITAL EGAS MONIZ, Lisboa, Portugal
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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