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The Effect of Milnacipran in Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01108731
First received: March 30, 2010
Last updated: October 13, 2014
Last verified: October 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[units: participants]
  13     13     26  
Age [1]
[units: years]
Mean ± Standard Deviation
  48  ± 4     47  ± 5     47  ± 4  
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  
[1] Age on intake, continuous



  Outcome Measures
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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


No publications provided


Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108731     History of Changes
Other Study ID Numbers: BIMC #212-09
Study First Received: March 30, 2010
Results First Received: July 7, 2014
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board