Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

Fibromyalgia Syndrome Clinical Trial

Official title:

Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757679
• Other study ID #: F02207 GE 205
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2008
• Last updated: July 10, 2013
• Start date: September 2006
• Est. completion date: September 2009

Study information

• Verified date: July 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes

Intervention

Drug:
• Milnacipran
capsules
• Placebo
capsules

Locations

Country	Name	City	State
Switzerland	Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre	Geneve

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.		7 weeks	No
Secondary	The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo		7 weeks	No
Secondary	The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations		7 weeks	No
Secondary	The safety/tolerability and compliance of 8 weeks of treatment with milnacipran		8 weeks	Yes
Secondary	The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations		7 weeks	No