Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
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| ClinicalTrials.gov Identifier: NCT01014585 |
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Recruitment Status :
Completed
First Posted : November 17, 2009
Results First Posted : September 7, 2011
Last Update Posted : September 7, 2011
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Sponsor:
Forest Laboratories
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
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| 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: Placebo Drug: Milnacipran |
| Enrollment | 340 |
Participant Flow
| Recruitment Details | 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 | 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. |
| Arm/Group Title | Responders: Placebo (Milnacipran Withdrawn) | Responders: Milnacipran (Milnacipran Continued) | Non-Responders: Placebo (Milnacipran Withdrawn) | Non-Responders: Milnacipran (Milnacipran Continued) |
|---|---|---|---|---|
 Arm/Group Description |
The Randomized Population for Responders | The Randomized Population for Responders | The Randomized Population for Non-Responders | The Randomized Population for Non-Responders |
| Period Title: Overall Study | ||||
| Started | 51 | 100 | 60 | 129 |
| Completed | 31 | 75 | 37 | 99 |
| Not Completed | 20 | 25 | 23 | 30 |
| Reason Not Completed | ||||
| 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| Withdrawn Due to Worsening Fibromyalgia | 18 | 23 | 22 | 22 |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
| Arm/Group Title | Responders: Placebo (Milnacipran Withdrawn) | Responders: Milnacipran (Milnacipran Continued) | Non-Responders: Placebo (Milnacipran Withdrawn) | Non-Responders: Milnacipran (Milnacipran Continued) | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
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. |
Safety Population for Responders: milnacipran treatment assignment | Safety Population for Non-Responders: placebo treatment assignment |
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 of all reporting groups | |
| Overall Number of Baseline Participants | 50 | 100 | 60 | 128 | 338 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 50 participants | 100 participants | 60 participants | 128 participants | 338 participants | |
| 54.0 (8.3) | 54.5 (9.3) | 54.7 (9.6) | 54.8 (9.4) | 54.6 (9.2) | ||
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Age, Customized
Measure Type: Number Unit of measure: Years |
Number Analyzed | 50 participants | 100 participants | 60 participants | 128 participants | 338 participants |
| Between 20 and 60 years | 39 | 73 | 38 | 86 | 236 | |
| >=60 years | 11 | 27 | 22 | 42 | 102 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 50 participants | 100 participants | 60 participants | 128 participants | 338 participants | |
| Female |
48 96.0%
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96 96.0%
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59 98.3%
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122 95.3%
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325 96.2%
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| Male |
2 4.0%
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4 4.0%
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1 1.7%
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6 4.7%
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13 3.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 50 participants | 100 participants | 60 participants | 128 participants | 338 participants |
| 50 | 100 | 60 | 128 | 338 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
All data generated in this study is the property of Forest Research Institute, Inc. An integrated clinical and statistical report was prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Results Point of Contact
| Name/Title: | Joel Trugman, MD |
| Organization: | Forest Research Institute, Inc., a subsidiary of Forest Laboratories, Inc. |
| Phone: | 201-427-8681 |
| EMail: | joel.trugman@frx.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01014585 |
| Other Study ID Numbers: |
MLN-MD-27 |
| First Submitted: | November 13, 2009 |
| First Posted: | November 17, 2009 |
| Results First Submitted: | June 7, 2011 |
| Results First Posted: | September 7, 2011 |
| Last Update Posted: | September 7, 2011 |