Fibromyalgia Syndrome
Conditions
Brief summary
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients
Interventions
DRUGMilnacipran
capsules
DRUGPlacebo
capsules
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patient with FMS according to the 1990 ACR criteria * patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates * patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics
Exclusion criteria
* severe psychiatric illness * current Major Depressive Episode (MDE) * significant risk of suicide * history of substance abuse * epilepsy * myocardial infarction in the past 24 months * active cardiac disease * congestive heart failure * prosthetic heart valve * haemodynamically significant valvular heart disease * known cardiac rhythm anomalies or conduction abnormalities * unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmHg * pulmonary dysfunction * active liver disease * renal impairment * documented autoimmune disease * current systemic infection * active cancer, except basal cell carcinoma or current cancer therapy * severe sleep apnoea * active peptic ulcer or inflammatory bowel disease (except IBS) * unstable endocrine disease * pregnancy or breastfeeding * concomitant use of non selective MAO inhibitors, MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs, NARIs, SNRIs, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines * concomitant use of oral anticoagulants, anticonvulsants, type Ic antiarrythmics, lithium * concomitant use of hypericum and SAMe * concomitant use of digitalis preparations * regular use of centrally-acting muscle relaxants * concomitant use of strong analgesics, including tramadol, codeine or opiates * any factor known to affect the HPA axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients. | 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo | 7 weeks |
| The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations | 7 weeks |
| The safety/tolerability and compliance of 8 weeks of treatment with milnacipran | 8 weeks |
| The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations | 7 weeks |
Countries
Switzerland
Outcome results
None listed