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OpenTrials
Completed

NCT Number: NCT00757679

Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Milnacipran

Drug

capsules

Placebo

Drug

capsules

Primary outcomes

  1. To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.

    Time frame: 7 weeks

Secondary outcomes

  1. The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo

    Time frame: 7 weeks

  2. The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations

    Time frame: 7 weeks

  3. The safety/tolerability and compliance of 8 weeks of treatment with milnacipran

    Time frame: 8 weeks

  4. The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 23, 2008
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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