Informations générales (source: ClinicalTrials.gov)
Interventional
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
avril 2013
novembre 2014
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Patient of more than 18 years old,
- Patient with fibromyalgia
- Patient of more than 18 years old,
- Patient with fibromyalgia
- 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.