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Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

This study has been terminated.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00793520
First received: November 17, 2008
Last updated: June 1, 2010
Last verified: June 2010
History of Changes
Results First Received: April 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: Milnacipran
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from November 2008 to April 2009 at one university location.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the five enrolled patients, only two received double-blind study medication due to equipment failure at the study site.

Reporting Groups
  Description
Milnacipran to Placebo Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Placebo to Placebo Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.

Participant Flow for 2 periods

 Period 1:   Milnacipran Crossover to Placebo
    Milnacipran to Placebo     Placebo to Placebo  
STARTED     1     0  
COMPLETED     0     0  
NOT COMPLETED     1     0  

Period 2:   Placebo Crossover to Milnacipran
    Milnacipran to Placebo     Placebo to Placebo  
STARTED     0     1  
COMPLETED     0     0  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Reporting Groups
  Description
Milnacipran to Placebo Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Placebo to Placebo Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Total Total of all reporting groups

Baseline Measures
    Milnacipran to Placebo     Placebo to Placebo     Total  
Number of Participants  
[units: participants]
 		  1     1     2  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  37     48     42.5  ± 7.78  
Gender  
[units: participants]
 		     
Female     1     1     2  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     1     1     2  



  Outcome Measures
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1.  Primary:   Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.   [ Time Frame: Week 0, 5, 7 and 12 ]
  Show Outcome Measure 1

2.  Secondary:   Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.   [ Time Frame: Weeks 0, 5, 7 and 12 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects enrolled. Technical problems with MRI equipment resulted in early study termination. No analysis was performed.  


Results Point of Contact:  
Name/Title: Allan Spera
Organization: Forest Research Institute
phone: 201-427-8399
e-mail: allan.spera@frx.com


No publications provided


Responsible Party: James Perhach, PhD, Executive Director, Clinical Development, Neurology, Forest Research Insititute
ClinicalTrials.gov Identifier: NCT00793520     History of Changes
Other Study ID Numbers: MLN-MD-16
Study First Received: November 17, 2008
Results First Received: April 15, 2010
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration