Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01328002 |
Recruitment Status :
Terminated
First Posted : April 4, 2011
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
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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 |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Primary Fibromyalgia |
Interventions |
Drug: Milnacipran Drug: Placebo |
Enrollment | 116 |
Participant Flow
Recruitment Details | Participants were recruited over a 12 month period from April of 2011 to April of 2012 at 47 study sites in the United States. |
Pre-assignment Details | 116 patients took at least 1 dose of open-label investigational product; 20 patients were randomized to receive double-blind treatment. |
Arm/Group Title | Milnacipran | Placebo |
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Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open-label phase of the study. Oral administration, twice daily dosing | [Not Specified] |
Period Title: Open-Label Period | ||
Started | 116 | 0 |
Completed | 20 | 0 |
Not Completed | 96 | 0 |
Reason Not Completed | ||
Inclusion/exclusion criteria not met | 66 | 0 |
Adverse Event | 8 | 0 |
Lack of Efficacy | 3 | 0 |
Protocol Violation | 2 | 0 |
Withdrawal by Subject | 9 | 0 |
Lost to Follow-up | 6 | 0 |
Other Reason | 2 | 0 |
Period Title: Double-Blind Period | ||
Started | 14 | 6 |
Completed | 12 | 6 |
Not Completed | 2 | 0 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Lack of Efficacy | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Open-Label Milnacipran | |
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Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined during the open label treatment phase. Oral administration, twice daily dosing | |
Overall Number of Baseline Participants | 116 | |
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All demographic data was based on the Open-Label Safety Population, which consists of 116 patients who took at least 1 dose of open-label milnacipran.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 116 participants | |
15.6 (1.4) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 116 participants |
13 years old | 10 | |
14 years old | 21 | |
15 years old | 21 | |
16 years old | 23 | |
17 years old | 41 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 116 participants | |
Female |
98 84.5%
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Male |
18 15.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 116 participants |
116 |
Outcome Measures
Adverse Events
Limitations and Caveats
Due to the early termination of the study, no firm conclusions about the use of milnacipran in pediatric patients for the treatment of primary fibromyalgia can be drawn.
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 will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be 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: | Therapeutic Area Head |
Organization: | Allergan |
Phone: | 714-246-4500 |
EMail: | clinicaltrials@allergan.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT01328002 |
Other Study ID Numbers: |
MLN-MD-14 |
First Submitted: | March 31, 2011 |
First Posted: | April 4, 2011 |
Results First Submitted: | August 21, 2013 |
Results First Posted: | May 14, 2019 |
Last Update Posted: | May 14, 2019 |