Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01077375
First received: February 25, 2010
Last updated: December 21, 2011
Last verified: December 2011
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: Placebo
Drug: Milnacipran

  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
Recruitment occurred over an 8 month period from February 2010 to September 2010 at 25 study centers in the United States. Last patient last visit occurred on December 22nd, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

All participants were given an open-label treatment of duloxetine 60 mg once daily for a two week period before randomization.

Patients randomized to placebo received 1 week of duloxetine 30 mg to effect a duloxetine down-taper. Patients randomized to milnacipran received 1 week of placebo capsules to maintain the blind.


Reporting Groups
  Description
Placebo Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
Milnacipran Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.

Participant Flow:   Overall Study
    Placebo     Milnacipran  
STARTED     21     86 [1]
COMPLETED     11     51  
NOT COMPLETED     10     35  
Adverse Event                 2                 15  
Lack of Efficacy                 6                 8  
Withdrawal by Subject                 0                 6  
Lost to Follow-up                 2                 5  
Other Reason                 0                 1  
[1] One randomized patient not taking study drug was excluded from the Double-blind Safety Population.



  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.
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Reporting Groups
  Description
Placebo Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
Milnacipran

Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.

One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.

Total Total of all reporting groups

Baseline Measures
    Placebo     Milnacipran     Total  
Number of Participants  
[units: participants]
  21     85     106  
Age  
[units: years]
Mean ± Standard Deviation
  48.5  ± 11.3     48.5  ± 10.5     48.5  ± 10.6  
Age, Customized  
[units: participants]
     
18 to 59     17     77     94  
60 to 70     4     8     12  
Gender  
[units: participants]
     
Female     19     79     98  
Male     2     6     8  
Region of Enrollment  
[units: participants]
     
United States     21     85     106  



  Outcome Measures
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1.  Primary:   Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)   [ Time Frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. ]

2.  Secondary:   Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score   [ Time Frame: Change from Baseline (Week 3) to Visit 5 (Week 13) ]


  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: Allan Spera, Director, Clinical Development
Organization: Forest Research Institute
phone: (201) 427-8399
e-mail: Allan.Spera@frx.com


No publications provided


Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01077375     History of Changes
Other Study ID Numbers: MLN-MD-28
Study First Received: February 25, 2010
Results First Received: December 21, 2011
Last Updated: December 21, 2011
Health Authority: United States: Food and Drug Administration