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Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

Primary Purpose

Fibromyalgia Syndrome

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Milnacipran
Placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Milnacipran

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations

Full Information

First Posted
September 22, 2008
Last Updated
July 10, 2013
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT00757679
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milnacipran
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Intervention Description
capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules
Primary Outcome Measure Information:
Title
To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
Time Frame
7 weeks
Title
The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
Time Frame
7 weeks
Title
The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
Time Frame
8 weeks
Title
The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations
Time Frame
7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jules Desmeules, MD
Organizational Affiliation
Centre Hospitalier HUG Genève - SUISSE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre
City
Geneve
Country
Switzerland

12. IPD Sharing Statement

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Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran

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