A EUROPEAN PHASE III, MULTICENTRE, DOUBLE-BLIND,RANDOMISED,PLACEBO-CONTROLLED, MONOTHERAPY STUDY OF MILNACIPRAN FOR THE TREATMENT OF THE FIBROMYALGIA SYNDROME. - ND
- Conditions
- 1990 ACR criteria for fibromyalgia syndromeMedDRA version: 6.1Level: PTClassification code 10048439
- Registration Number
- EUCTR2005-003137-40-IT
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 824
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 25 at the end of the wash-out period and at randomisation. With a FIQ-PF 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of milnacipran 200 mg/day as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion incorporating two domains pain and patient global status, and key secondary criteria measuring physical and emotional functioning.;Secondary Objective: To compare the efficacy of 200 mg/day of milnacipran to placebo on a number of additional secondary criteria To establish the safety profile of 200 mg/day of milnacipran in patients with FMS;Primary end point(s): Primary parameter responder status based on two patient self-reported assessments on the PED Morning 24h Recall Pain Score and Patient Global Impression of Change PGIC .
- Secondary Outcome Measures
Name Time Method