Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran
1 other identifier
interventional
153
1 country
1
Brief Summary
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJuly 11, 2013
July 1, 2013
3 years
September 22, 2008
July 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
7 weeks
Secondary Outcomes (4)
The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
7 weeks
The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
7 weeks
The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
8 weeks
The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations
7 weeks
Study Arms (2)
Milnacipran
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre
Geneva, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jules Desmeules, MD
Centre Hospitalier HUG Genève - SUISSE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2008
First Posted
September 23, 2008
Study Start
September 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 11, 2013
Record last verified: 2013-07