Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)
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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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Tracking Information | ||||
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First Submitted Date ICMJE | March 31, 2011 | |||
First Posted Date ICMJE | April 4, 2011 | |||
Results First Submitted Date ICMJE | August 21, 2013 | |||
Results First Posted Date ICMJE | May 14, 2019 | |||
Last Update Posted Date | May 14, 2019 | |||
Actual Study Start Date ICMJE | April 30, 2011 | |||
Actual Primary Completion Date | August 31, 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo. [ Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16) ] 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
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Original Primary Outcome Measures ICMJE |
Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Patient Global Impression of Severity (PGIS) [ Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16) ] 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
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Original Secondary Outcome Measures ICMJE |
Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia | |||
Official Title ICMJE | A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia | |||
Brief Summary | The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Primary Fibromyalgia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
116 | |||
Original Estimated Enrollment ICMJE |
312 | |||
Actual Study Completion Date ICMJE | August 31, 2012 | |||
Actual Primary Completion Date | August 31, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01328002 | |||
Other Study ID Numbers ICMJE | MLN-MD-14 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Forest Laboratories | |||
Original Responsible Party | Stephen M. Graham, PhD, Forest Research Institute | |||
Current Study Sponsor ICMJE | Forest Laboratories | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Cypress Bioscience, Inc. | |||
Investigators ICMJE |
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PRS Account | Forest Laboratories | |||
Verification Date | March 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |