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The Effect of Milnacipran in Patients With Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108731
First Posted: April 22, 2010
Last Update Posted: June 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Beth Israel Medical Center
Results First Submitted: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We got informed consent from 37 patients but excluded 3 -- 2 for saving psychiatric diagnoses that were exclusionary and one for having a metal implant which was an exclusion for neuroimaging. Thus 34 patients were randomized for the trial.

Reporting Groups
  Description
Patients Taking the Drug Minalcipran Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
Patients Taking the Placebo Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.

Participant Flow:   Overall Study
    Patients Taking the Drug Minalcipran   Patients Taking the Placebo
STARTED   17   17 
COMPLETED   13   13 
NOT COMPLETED   4   4 
Withdrawal by Subject                1                1 
Adverse Event                3                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Had to report widespread pain and to have at least 11 of 18 tender points [rated on a 0 to 10 pain intensity scale at 2 or higher].

Reporting Groups
  Description
Patients Taking the Drug Minalcipran Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
Patients Taking the Placebo Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Total Total of all reporting groups

Baseline Measures
   Patients Taking the Drug Minalcipran   Patients Taking the Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   13   26 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 48  (4)   47  (5)   47  (4) 
[1] Age on intake, continuous
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   13   26 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   13   13   26 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   13   13   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Ventricular Lactate Levels in the Brain   [ Time Frame: Baseline and 2 months ]

2.  Secondary:   Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).   [ Time Frame: Baseline and 2 months ]

3.  Secondary:   Change in Widespread Pain   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Benjamin Natelson
Organization: Beth_IsraelMC
phone: 212-844-6747
e-mail: bnatelson@chpnet.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108731     History of Changes
Other Study ID Numbers: BIMC #212-09
First Submitted: March 30, 2010
First Posted: April 22, 2010
Results First Submitted: July 7, 2014
Results First Posted: October 15, 2014
Last Update Posted: June 30, 2016