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

NCT01747044 | Unknown Phase 2

• 1 other identifier: CHU-0130
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromylagia

Keywords

Fibromyalgia; Diffuse Noxious Inhibitory Controls; Milnacipran

Outcome Measures

Primary Outcomes (1)

• Pain scores on the verbal numeric scale

  at T0 and T0+1 month

Secondary Outcomes (4)

• sensitivity and pain thresholds to a mechanical stimulus

  at T0 and T0+1 month

• sensitivity and pain thresholds to a thermal stimulus

  at T0 and T0+1 month

• scores on cognitive tests

  at T0 and T0+1 month

• Adverse events record

  at T0 and T0+1 month

Study Arms (2)

Milnacipran

ACTIVE COMPARATOR

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

Capsules of lactose

PLACEBO COMPARATOR

placebo over a period of 8 weeks to 24 weeks

Drug: Placebo

Interventions

Milnacipran DRUG

100mg/day

Milnacipran

Placebo DRUG

Capsules of lactose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-501 - Main investigator: collaborator
• Dr Pascale PICARD/ Dr Noémie Delage / Dr Fabienne RIAUX - Center of evaluation and treatment of the pain - Investigator: collaborator
• Dr Gilles DUCHEIX/ Center of clinical pharmacology/CIC Inserm-501 - Investigator: collaborator
• Dr Christian DUALE/ Center of clinical pharmacology/CIC Inserm-501 - Investigator: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• Macian N, Pereira B, Shinjo C, Dubray C, Pickering G. Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial. Trials. 2015 Apr 3;16:134. doi: 10.1186/s13063-015-0659-4.

  PMID: 25873248 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 11, 2012
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)