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Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran
This study is currently recruiting participants.
Verified by Pierre Fabre Medicament, September 2008
First Received: September 22, 2008   No Changes Posted
Sponsored by: Pierre Fabre Medicament
Information provided by: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT00757679
  Purpose

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


Condition Intervention Phase
Fibromyalgia Syndrome
Drug: Milnacipran
Phase II

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Milnacipran hydrochloride Milnacipran
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-Controlled Clinical Trial in Fibromyalgia Out-Patients

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.

Secondary Outcome Measures:
  • The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
  • The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
  • The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
  • The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations

Estimated Enrollment: 80
Study Start Date: September 2006
Estimated Study Completion Date: October 2009
Intervention Details:
    Drug: Milnacipran
    capsules
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757679

Contacts
Contact: Yves MAINGUY, MD +33 5 62 24 27 40 yves.mainguy@pierre-fabre.com

Locations
Switzerland
Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre Recruiting
GENEVE, Switzerland
Contact: jules desmeules, MD     41 22 382 99 32     jules.desmeules@hcuge.ch    
Principal Investigator: jules Desmeules, MD            
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
Principal Investigator: Jules Desmeules, MD Centre Hospitalier HUG Genève - SUISSE
  More Information

No publications provided

Study ID Numbers: F02207 GE 205
Study First Received: September 22, 2008
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00757679     History of Changes
Health Authority: Switzerland: Swissmedic

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Fibromyalgia
Myofascial Pain Syndromes
Psychotropic Drugs
Pain
Rheumatic Diseases
Serotonin Uptake Inhibitors
Serotonin
Milnacipran
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Analgesics
Peripheral Nervous System Agents
Antidepressive Agents

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Pathologic Processes
Neuromuscular Diseases
Musculoskeletal Diseases
Sensory System Agents
Syndrome
Therapeutic Uses
Analgesics
Antidepressive Agents
Disease
Myofascial Pain Syndromes
Fibromyalgia
Nervous System Diseases
Rheumatic Diseases
Serotonin Uptake Inhibitors
Pharmacologic Actions
Milnacipran
Muscular Diseases
Serotonin Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009