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Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00797797
First received: November 24, 2008
Last updated: January 20, 2011
Last verified: January 2011
Results First Received: November 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: No Treatment Added
Drug: Milnacipran Added

  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
Participants were recruited and enrolled in this study within the US from December 2008 to June 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entered an open label pregabalin period concurrent with prohibited medication washout. Incomplete responders to pregabalin were randomized to receive either milnacipran (100 mg/d) or no added treatment for 11 weeks. All participant continued background stable dose pregabalin (300 or 450 mg/d) throughout the randomized treatment period.

Reporting Groups
  Description
No Treatment Added No treatment added for 11 weeks of randomized treatment period
Milnacipran Added Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period

Participant Flow:   Overall Study
    No Treatment Added     Milnacipran Added  
STARTED     178 [1]   184  
COMPLETED     123     141  
NOT COMPLETED     55     43  
[1] Two patients took no background stable dose of pregabalin after randomization and are not included.



  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.
No text entered.

Reporting Groups
  Description
No Treatment Added No treatment added for 11 weeks of randomized treatment period
Milnacipran Added Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
Total Total of all reporting groups

Baseline Measures
    No Treatment Added     Milnacipran Added     Total  
Number of Participants  
[units: participants]
  178     184     362  
Age  
[units: participants]
     
Between 18 and 60 years     151     146     297  
>=60 years     27     38     65  
Age  
[units: years]
Mean ± Standard Deviation
  48.8  ± 10.4     49.8  ± 10.3     49.3  ± 10.3  
Gender  
[units: participants]
     
Female     159     170     329  
Male     19     14     33  
Region of Enrollment  
[units: participants]
     
United States     178     184     362  



  Outcome Measures
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1.  Primary:   Patient Global Impression of Change (PGIC) Responder Rate at End of Study   [ Time Frame: End of Randomized treatment period (11 weeks) ]

2.  Secondary:   Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study   [ Time Frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) ]


  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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert Palmer, MD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
phone: 1-201-427-8218
e-mail: robert.palmer@frx.com


No publications provided


Responsible Party: James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
ClinicalTrials.gov Identifier: NCT00797797     History of Changes
Other Study ID Numbers: MLN-MD-15
Study First Received: November 24, 2008
Results First Received: November 18, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration