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

This study is not yet open for participant recruitment.
Verified December 2012 by University Hospital, Clermont-Ferrand
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
Pr Claude DUBRAY (PU, PH) Center of clinical pharmacology/CIC Inserm-501 - 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
ClinicalTrials.gov Identifier:
NCT01747044
First received: November 27, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Fibromylagia
Drug: Milnacipran
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Pain scores on the verbal numeric scale [ Time Frame: at T0 and T0+1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • sensitivity and pain thresholds to a mechanical stimulus [ Time Frame: at T0 and T0+1 month ] [ Designated as safety issue: Yes ]
  • sensitivity and pain thresholds to a thermal stimulus [ Time Frame: at T0 and T0+1 month ] [ Designated as safety issue: Yes ]
  • scores on cognitive tests [ Time Frame: at T0 and T0+1 month ] [ Designated as safety issue: Yes ]
  • Adverse events record [ Time Frame: at T0 and T0+1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747044

Contacts
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
Pr Claude DUBRAY (PU, PH) Center of clinical pharmacology/CIC Inserm-501 - 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
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01747044     History of Changes
Other Study ID Numbers: CHU-0130
Study First Received: November 27, 2012
Last Updated: December 10, 2012
Health Authority: France: Ministry of Health

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on April 17, 2014