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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00436033
• Date of registration: 15/02/2007
• Prospective Registration: No
• Primary sponsor: Pierre Fabre Medicament
• Public title: A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
• Scientific title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
• Date of first enrolment: February 2006
• Target sample size: 1429
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00436033
• 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
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Dr Jaime C BRANCO
• Affiliation: HOSPITAL EGAS MONIZ

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia Syndrome

Intervention(s)

Drug: Placebo

Drug: milnacipran

Primary Outcome(s)

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 [Time Frame: 12 weeks]

Secondary Outcome(s)

establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS). [Time Frame: 19 weeks]

comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria [Time Frame: 12 weeks]

Secondary ID(s)

F02207GE302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors