Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, widespread tenderness and fatigue. The disorder is well defined in the USA, where the current diagnosis of FMS is based on the criteria set forth by the American College of Rheumatology (ACR) in 19901.
Conditions
Interventions
Product Name: N/A
Product Code: F02207
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: milnacipran hydrochloride
Current Sponsor
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have Fibromyalgia according to the 1990 ACR criteria and recruited from primary care. 2. Female patients between the ages of 18 and 55 years. 3. Right-handed. 4. Females must be either postmenopausal (no menses for at least 1 year) or status-post hysterectomy or oophorectomy (bilateral) or, if of childbearing potential, must have a negative urine pregnancy test prior randomization, and be using a medically acceptable form of contraception for about two months before the inclusion in this study (i.e., hormonal birth control, IUD), The contraception should be continued one month after the intake of the last dose of study treatment. 5. Patients must have the ability to give informed consent. 6. Patients must be willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsants, mood stabilizers, opioids, narcotic patches 7. Patients must be willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender and trigger point injections, acupuncture, and anesthetic. 8. Patients must have a VAS intensity pain scale over last week before randomisation of at least 40 on a 0-100mm scale at baseline Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For all patients with severe physical impairment (e.g., bilateral amputation, complete blindness or deafness), medical conditions that were capable of causing patients’ symptoms (e.g., morbid obesity, autoimmune/inflammatory diseases), cardiopulmonary disorders (i.e., angina pectoris, congestive heart failure, COPD, chronic asthma), arterial hypertension, hepatic or chronic renal insufficiency, uncontrolled endocrine or allergic disorders (i.e., hyper-/hypothyroidism, diabetes, allergic rhinitis), malignancy, severe psychiatric illnesses (e.g., current schizophrenia, current major depressive episode), substance abuse within the past two years)Patient with abnormal standard ECG at screening Patient with intracranial anomaly during the first fMRI session Patient who is receiving concomitant drug therapy included in the table in appendix 17.6 of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 12 weeks of treatment with Milnacipran on sensitivity to stimulus-evoked pain in out-patients with fibromyalgia syndrome.;Primary end point(s): Change in pain perception: shift of the stimulus-response curves (Pressure-pain sensitivity by subjective scaling of multiple pressure-pain sensations of suprathreshold intensities); Secondary Objective: To assess the correlation between the effect of Milnacipran on sensitivity to stimulus-evoked pain and findings on functional Magnetic Resonance Imaging (fMRI). To identify baseline measures that predict response to treatment. To assess the safety and tolerability of 12 weeks of treatment with Milnacipran. | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed