Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia Syndrome

Treatments: Drug: Placebo; Drug: Milnacipran

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757679

F02207 GE 205

Details and patient eligibility

About

Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients

Enrollment: 153 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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153 participants in 2 patient groups, including a placebo group

Milnacipran

Experimental group

Treatment:

Drug: Milnacipran

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo