Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

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

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Drug: Milnacipran; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Geneve, Switzerland
    • Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; capsules
Experimental: Milnacipran	Drug: Milnacipran; capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament
• Investigators: Principal Investigator: Jules Desmeules, MD, Centre Hospitalier HUG Genève - SUISSE

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Milnacipran; Levomilnacipran
• Other Study ID Numbers: F02207 GE 205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No