Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

Phase 2

Completed

• Conditions: Fibromyalgia Syndrome
• Interventions: Drug: Placebo; Drug: Milnacipran

• Registration Number: NCT00757679
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Milnacipran	Milnacipran	-

Primary Outcome Measures

Name	Time	Method
To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.	7 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre; 🇨🇭 Geneve, Switzerland