Fibromyalgia Syndrome
Conditions
Brief summary
Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.
Interventions
DRUGmilnacipran
hard capsule
DRUGPlacebo
hard capsule
Sponsors
Pierre Fabre Medicament
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 71 Years
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
* 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
Design outcomes
Primary
| 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 | 12 months |
Secondary
| 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 | 12 months |
Countries
Czechia, Finland, France, Germany, Italy, Norway, Portugal, Romania, Spain, Sweden
Outcome results
None listed