Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

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

Official Title
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Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients

Conditions
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Fibromyalgia Syndrome

Intervention / Treatment
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* Drug: Milnacipran
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milnacipran<br> | Drug: Milnacipran<br>* capsules<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients. |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |