A European Phase III, Multicentre, Double-blind, Randomised, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome. - FMS Europe

• Conditions: Fibromyalgia, also known as FMS, is a common systemic rheumatologic disorder estimated to affect 2 to 4% of the population Fibromyalgia is associated with a reduced threshold for pain, generally identified by an increased sensitivity to pressure at particular points on the body, and is often accompanied by fatigue, sleep disturbance, and morning stiffness. Other common symptoms include headache, migraine, variable bowel habits, diffuse abdominal pain, and urinary frequency.

• Registration Number: EUCTR2005-003137-40-SE
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 824

Inclusion Criteria

Female or male patient aged 18 - 70 years with a diagnosis of fibromyalgia according to the 1990 ACR criteria.
(for women) Either postmenopausal (no menses for at least 1 year) or -has a post-hysterectomy, -oophorectomy (bilateral), -tubal ligation status or, if of childbearing potential, has a negative urine pregnancy test at BL1 Visit/V2/D-14, and has been using a medically acceptable form of contraception for about two months before the inclusion in this study (i.e., hormonal birth control, IUD, double barrier [male condom, female condom, diaphragm] or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream]). The patient should be advised to continue the contraception one month after the intake of the last dose of study treatment.
Is able to give an informed consent.
Is willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsants, mood stabilizers, opioids and central anaesthetics (ketamine) whatever the route of administration.
Is willing to discontinue treatment with transcutaneous electrical nerve stimulation, trigger point, tender point or joint injections, acupuncture, and local anaesthetics (patches).
Is able to read and understand the text in local language on the Patient Electronic Diary (PED) screen.
Is able to hear and respond to the PED audible prompts.
Is willing and able to use a PED device daily for a minimum of 21 weeks.
Has at least 10 PED morning reports over the 14 relevant days of the baseline period (i.e., the 14 days immediately prior to randomisation). The baseline period must be a minimum of 14 days.
With an average VAS intensity pain scale recording (based on the electronic diary daily pain recall) between 40 and 90 units (both limits included) on a 0-100 units scale at the end of the baseline period (over 14 days).
With a BDI With a FIQ-PF >or= to 3 at randomisation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

With a severe psychiatric illness and significant risk of suicide at screening (V1) or randomisation (V3) according to the MINI performed by a trained staff.
With a current major depressive episode (MDE-current), or a generalised anxiety disorder (GAD) at screening (V1) or randomisation (V3) as defined by the MINI performed by a trained staff.
Abusing of alcohol, benzodiazepines or other drugs, substances (cannabis) as defined by the MINI performed by trained staff at screening (V1). Patients with a positive urine drug screen for benzodiazepines and opiates at BL1 Visit (V2/D-14) will not be included.
With a history or behaviour that would, in the Investigator’s estimation, prohibit compliance for the duration of the study.
With myocardial infarction within the past 24 months, active cardiac disease (American Heart Association Functional Class 2, 3 or 4), congestive heart failure, haemodynamically significant valvular heart disease (including patients with a prosthetic heart valve), and/or clinically significant cardiac rhythm or conduction abnormalities and/or unstable or uncontrolled hypertension.
With pulmonary dysfunction or severe chronic obstructive pulmonary disease that, in the Investigator’s judgment, could interfere with the study participation and completion.
With evidence of active liver disease (levels of AST, ALT and/or alkaline phosphatase >1.5x the upper limit of the normal range for the laboratory performing the test).
With renal impairment (Cockroft creatinine clearance < 60 ml/min: adjustment for patient gender, age and lean body mass).
With documented systemic autoimmune disease.
With chronic inflammatory rheumatoid disease.
With current systemic infection.
Epileptic.
With active cancer, (except basal cell carcinoma), or patients currently undergoing therapy for cancer.
With a current life expectancy less than one year.
With sleep apnea severe enough that, in the Investigator‘s opinion, it would interfere with interpretation of changes in sleep habits.
With active peptic ulcer, inflammatory bowel disease.
With unstable endocrine disease, including unstable diabetes or thyroid disease. Disorders that have been stable under treatment for the preceding 3 months before screening will be acceptable.
(for men) With prostatic enlargement or other genito-urinary disorders, that might be at significant risk of dysuria and/or urinary retention when taking agents with noradrenaline re-uptake inhibition properties.
(for women) Pregnant or breastfeeding.
With a known hypersensitivity to milnacipran
Has received treatment with an experimental agent within the last 30 days before screening.
Is receiving concomitant therapy with MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs agents, NARIs agents, SNRIs agents or alpha-agonists, anticonvulsants (phenytoin), dopamine agonists, or muscle relaxants.
Is receiving concomitant therapy with metabolic enzyme inhibitors (i.e., cimetidine) and enzyme inducers (including phenytoin and phenobarbital), oral anticoagulants (warfarin), type 1C antiarrhythmics (propafenone, flecainide, encainide).
Is receiving concomitant therapy with epinephrine, norepinephrine (alpha and beta sympathomimetics) especially when given by parenteral route.
Has been receiving statines, except if stable, for 4 weeks prior to randomisation.
With concurrent usage of hypericum, SAMe, melatonine, or DHEA.
With concurrent usage of digitalis (digoxin) preparations.
With concurrent usage of centrally acting analges

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified