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Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)

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
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Open-Label Milnacipran
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 116 participants
Female
98
  84.5%
Male
18
  15.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 116 participants
116
1.Primary Outcome
Title Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
Hide Description During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances
Time Frame Change from Visit 7 (Week 8) to Visit 10 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients who were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat [ITT] Population).
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
Dose matched placebo, oral administration, twice daily dosing
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
Overall Number of Participants Analyzed 6 14
Mean (Standard Deviation)
Unit of Measure: Days
NA [1]   (NA) 7.0  (1.4)
[1]
No patients in the placebo arm experienced a loss of therapeutic effect during the double-blind study period.
2.Secondary Outcome
Title Patient Global Impression of Severity (PGIS)
Hide Description The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill
Time Frame Change from Visit 7 (Week 8) to Visit 10 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat [ITT] Population).
Arm/Group Title Placebo Milnacipran
Hide Arm/Group Description:
Dose matched placebo, oral administration, twice daily dosing
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
Overall Number of Participants Analyzed 6 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (0.8) 0.4  (0.9)
Time Frame Adverse Event data was collected over a 17-month period from April, 2011 to September, 2012
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Milnacipran - Open-Label Treatment Period Placebo - Double Blind-Treatment Milnacipran - Double-Blind Treatment Period
Hide Arm/Group Description Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during a four-week dose escalation period, and then continued at the maximum tolerated dose for an additional four weeks. Oral administration, twice daily dosing Dose matched placebo, oral administration, twice daily dosing 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
All-Cause Mortality
Milnacipran - Open-Label Treatment Period Placebo - Double Blind-Treatment Milnacipran - Double-Blind Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Milnacipran - Open-Label Treatment Period Placebo - Double Blind-Treatment Milnacipran - Double-Blind Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/6 (0.00%)   1/14 (7.14%) 
Psychiatric disorders       
Suicidal Ideation † 1  0/116 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Milnacipran - Open-Label Treatment Period Placebo - Double Blind-Treatment Milnacipran - Double-Blind Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/116 (53.45%)   4/6 (66.67%)   6/14 (42.86%) 
Blood and lymphatic system disorders       
Anaemia † 1  1/116 (0.86%)  1/6 (16.67%)  0/14 (0.00%) 
Cardiac disorders       
Tachycardia † 1  7/116 (6.03%)  0/6 (0.00%)  1/14 (7.14%) 
Eye disorders       
Blepharospasm † 1  0/116 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Gastrointestinal disorders       
Abdominal pain lower † 1  1/116 (0.86%)  1/6 (16.67%)  0/14 (0.00%) 
Abdominal discomfort † 1  2/116 (1.72%)  0/6 (0.00%)  1/14 (7.14%) 
Nausea † 1  38/116 (32.76%)  0/6 (0.00%)  0/14 (0.00%) 
Vomiting † 1  16/116 (13.79%)  0/6 (0.00%)  0/14 (0.00%) 
General disorders       
Pyrexia † 1  0/116 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Noncardiac chest pain † 1  1/116 (0.86%)  0/6 (0.00%)  1/14 (7.14%) 
Fatigue † 1  7/116 (6.03%)  0/6 (0.00%)  0/14 (0.00%) 
Infections and infestations       
Anorectal infection † 1  0/116 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Bronchitis † 1  1/116 (0.86%)  1/6 (16.67%)  0/14 (0.00%) 
Upper respiratory tract infection † 1  5/116 (4.31%)  0/6 (0.00%)  1/14 (7.14%) 
Investigations       
Blood pressure diastolic increased † 1  0/116 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Liver function test abnormal † 1  0/116 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Weight increased † 1  0/116 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite † 1  5/116 (4.31%)  0/6 (0.00%)  2/14 (14.29%) 
Nervous system disorders       
Headache † 1  12/116 (10.34%)  1/6 (16.67%)  0/14 (0.00%) 
Dizziness † 1  10/116 (8.62%)  0/6 (0.00%)  0/14 (0.00%) 
Psychiatric disorders       
Anxiety † 1  0/116 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Suicidal ideation † 1  0/116 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Vascular disorders       
Hot flush † 1  7/116 (6.03%)  0/6 (0.00%)  0/14 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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.
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.
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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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