Status:
COMPLETED
Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Fibromyalgia Syndrome
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00757679
Start Date
September 1 2006
End Date
September 1 2009
Last Update
July 11 2013
Active Locations (1)
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1
Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre
Geneva, Switzerland