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Prospective Study of the Influence of the Diffuse Noxious Inhibitory Controls of the Pain on the Efficacy of Milnacipran in Fibromyalgia Therapy

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ClinicalTrials.gov Identifier: NCT01747044
Recruitment Status : Unknown
Verified July 2014 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : December 11, 2012
Last Update Posted : July 8, 2014
Sponsor:
Collaborators:
Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-501 - Main investigator
Dr Pascale PICARD/ Dr Noémie Delage / Dr Fabienne RIAUX - Center of evaluation and treatment of the pain - Investigator
Dr Gilles DUCHEIX/ Center of clinical pharmacology/CIC Inserm-501 – Investigator
Dr Christian DUALE/ Center of clinical pharmacology/CIC Inserm-501 - Investigator
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. In France, the prevalence is 1.6% according to a French study conducted in 2009 and published in 2011 by Serge Perrot et al.

The definition of fibromyalgia was recently amended with particular consideration of cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR classification. Several factors are in favor of a malfunction of the central modulation of pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction of the central pain modulation is widely described in the literature and contributes to pain complained of fibromyalgia.

According to the Recommendations of the European League Against Rheumatism (EULAR) 2006, antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR. A review included five double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of participants treated for each dose of milnacipran on the criteria of "at least 30% pain relief" Impression and global change. Substantial improvement with milnacipran compared to placebo has been shown.

To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug treatment has not been shown.

This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be predictive of the efficacy of milnacipran.


Condition or disease Intervention/treatment Phase
Fibromylagia Drug: Milnacipran Drug: Placebo Phase 2

Detailed Description:

Visit 1 Inclusion of the patient, Clinical examination, Evaluation of pain, basal Pain and cognitive tests

Visit 2 (can be coupled with Visit 1 if necessary) Randomisation of the patient and allocation of the treatment for 1 month.

Phone contact Visit 2 +7 days, + 15 days, +21 days Follow-up of the compliance of the treatment and collection of adverse events.

Visit 3 (follow up at 1 month) Evaluation of pain, Pain and cognitive tests End of study


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Milnacipran
Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR
Drug: Milnacipran
100mg/day
Placebo Comparator: Capsules of lactose
placebo over a period of 8 weeks to 24 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Pain scores on the verbal numeric scale [ Time Frame: at T0 and T0+1 month ]

Secondary Outcome Measures :
  1. sensitivity and pain thresholds to a mechanical stimulus [ Time Frame: at T0 and T0+1 month ]
  2. sensitivity and pain thresholds to a thermal stimulus [ Time Frame: at T0 and T0+1 month ]
  3. scores on cognitive tests [ Time Frame: at T0 and T0+1 month ]
  4. Adverse events record [ Time Frame: at T0 and T0+1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient of more than 18 years old,
  • Patient with fibromyalgia

Exclusion Criteria:

  • Patient with a contraindication to the administration of the milnacipran,
  • Patient with a concomitant spontaneous pain not attributable of fibromyalgia,
  • Patient with medical and/or surgical histories judged by the investigator not compatible with the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747044


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-501 - Main investigator
Dr Pascale PICARD/ Dr Noémie Delage / Dr Fabienne RIAUX - Center of evaluation and treatment of the pain - Investigator
Dr Gilles DUCHEIX/ Center of clinical pharmacology/CIC Inserm-501 – Investigator
Dr Christian DUALE/ Center of clinical pharmacology/CIC Inserm-501 - Investigator
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01747044     History of Changes
Other Study ID Numbers: CHU-0130
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by University Hospital, Clermont-Ferrand:
Fibromyalgia
Diffuse Noxious Inhibitory Controls
Milnacipran

Additional relevant MeSH terms:
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents