A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00436033

Enrollment

1429

Registered

2007-02-16

Start date

2006-02-28

Completion date

2007-09-30

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Syndrome

Brief summary

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

Interventions

DRUGmilnacipran

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion criteria

* psychiatric illness * depression of generalised anxiety disorder * suicidal risk * substance abuse * active cardiac disease * pulmonary dysfunction * liver disease * renal impairment * autoimmune disease * chronic inflammatory rheumatoid disease * current systemic infection * epileptic * active cancer * sleep apnea * active peptic ulcer * inflammatory bowel disease * unstable endocrine disease * for men : prostatic enlargement of genito-urinary disorders * for women : pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion	12 weeks

Secondary

Measure	Time frame
comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria	12 weeks
establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).	19 weeks

Countries

Czechia, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Romania, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026