Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Discontinuation Study of the Durability of Effect of Milnacipran 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:
NCT01014585
First received: November 13, 2009
Last updated: September 2, 2011
Last verified: September 2011
Results First Received: June 7, 2011  
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: Placebo
Drug: Milnacipran

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was from November 2009 through February 2010 at 58 centers in the United States with the last patient visit occurring on June 7, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Upon completion of a long term milnacipran open label study MLN-MD-06, patients were enrolled in the current study MLN-MD-27 (NCT01014585), and received open label treatment with milnacipran for four weeks prior to randomization.

Reporting Groups
  Description
Responders: Placebo (Milnacipran Withdrawn) The Randomized Population for Responders
Responders: Milnacipran (Milnacipran Continued) The Randomized Population for Responders
Non-Responders: Placebo (Milnacipran Withdrawn) The Randomized Population for Non-Responders
Non-Responders: Milnacipran (Milnacipran Continued) The Randomized Population for Non-Responders

Participant Flow:   Overall Study
    Responders: Placebo (Milnacipran Withdrawn)     Responders: Milnacipran (Milnacipran Continued)     Non-Responders: Placebo (Milnacipran Withdrawn)     Non-Responders: Milnacipran (Milnacipran Continued)  
STARTED     51     100     60     129  
COMPLETED     31     75     37     99  
NOT COMPLETED     20     25     23     30  
Adverse Event                 0                 2                 0                 3  
Withdrawal by Subject                 2                 0                 1                 3  
Lost to Follow-up                 0                 0                 0                 2  
Withdrawn Due to Worsening Fibromyalgia                 18                 23                 22                 22  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Responders: Placebo (Milnacipran Withdrawn)

Safety Population for Responders: placebo treatment assignment

One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population.

Responders: Milnacipran (Milnacipran Continued) Safety Population for Responders: milnacipran treatment assignment
Non-Responders: Placebo (Milnacipran Withdrawn) Safety Population for Non-Responders: placebo treatment assignment
Non-Responders: Milnacipran (Milnacipran Continued)

Safety Population for Non-Responders: milnacipran treatment assignment

One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population.

Total Total of all reporting groups

Baseline Measures
    Responders: Placebo (Milnacipran Withdrawn)     Responders: Milnacipran (Milnacipran Continued)     Non-Responders: Placebo (Milnacipran Withdrawn)     Non-Responders: Milnacipran (Milnacipran Continued)     Total  
Number of Participants  
[units: participants]
  50     100     60     128     338  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 8.3     54.5  ± 9.3     54.7  ± 9.6     54.8  ± 9.4     54.6  ± 9.2  
Age, Customized  
[units: Years]
         
Between 20 and 60 years     39     73     38     86     236  
>=60 years     11     27     22     42     102  
Gender  
[units: participants]
         
Female     48     96     59     122     325  
Male     2     4     1     6     13  
Region of Enrollment  
[units: participants]
         
United States     50     100     60     128     338  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Loss of Therapeutic Response (LTR)   [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]

2.  Secondary:   Time to Worsening in Patient Global Impression of Change (PGIC)   [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]

3.  Secondary:   Time to Worsening in Multidimensional Assessment of Fatigue (MAF)   [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: Joel Trugman, MD
Organization: Forest Research Institute, Inc., a subsidiary of Forest Laboratories, Inc.
phone: 201-427-8681
e-mail: joel.trugman@frx.com


No publications provided by Forest Laboratories

Publications automatically indexed to this study:

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01014585     History of Changes
Other Study ID Numbers: MLN-MD-27
Study First Received: November 13, 2009
Results First Received: June 7, 2011
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration