Clinical trial NCT00757679: Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran
Official title: Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia Syndrome
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients


Eligibility criteria: Inclusion Criteria:

* patient with FMS according to the 1990 ACR criteria
* patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates
* patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics

Exclusion Criteria:

* severe psychiatric illness
* current Major Depressive Episode (MDE)
* significant risk of suicide
* history of substance abuse
* epilepsy
* myocardial infarction in the past 24 months
* active cardiac disease
* congestive heart failure
* prosthetic heart valve
* haemodynamically significant valvular heart disease
* known cardiac rhythm anomalies or conduction abnormalities
* unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmHg
* pulmonary dysfunction
* active liver disease
* renal impairment
* documented autoimmune disease
* current systemic infection
* active cancer, except basal cell carcinoma or current cancer therapy
* severe sleep apnoea
* active peptic ulcer or inflammatory bowel disease (except IBS)
* unstable endocrine disease
* pregnancy or breastfeeding
* concomitant use of non selective MAO inhibitors, MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs, NARIs, SNRIs, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines
* concomitant use of oral anticoagulants, anticonvulsants, type Ic antiarrythmics, lithium
* concomitant use of hypericum and SAMe
* concomitant use of digitalis preparations
* regular use of centrally-acting muscle relaxants
* concomitant use of strong analgesics, including tramadol, codeine or opiates
* any factor known to affect the HPA axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)

Primary outcomes:
measure: To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
timeFrame: 7 weeks
Secondary outcomes:
measure: The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
timeFrame: 7 weeks
measure: The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
timeFrame: 7 weeks
measure: The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
timeFrame: 8 weeks
measure: The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre
Study officials:
affiliation: Centre Hospitalier HUG Genève - SUISSE
name: Jules Desmeules, MD
role: PRINCIPAL_INVESTIGATOR
References: