Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Analgesics; Levomilnacipran; Milnacipran

Criteria

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)