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

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

Tracking Information

• First Submitted Date: March 31, 2011
• First Posted Date: April 4, 2011
• Results First Submitted Date: August 21, 2013
• Results First Posted Date: May 14, 2019
• Last Update Posted Date: May 14, 2019
• Actual Study Start Date: April 30, 2011
• Actual Primary Completion Date: August 31, 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2019)

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

• Original Primary Outcome Measures (submitted: April 1, 2011): Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ]

Current Secondary Outcome Measures (submitted: April 23, 2019)

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

• Original Secondary Outcome Measures (submitted: April 1, 2011): 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: Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
• Official Title: 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

• 8 weeks open-label treatment period with milnacipran.
• Followed by randomization to 8-weeks double blind treatment period for eligible patients

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Primary Fibromyalgia

Intervention

• Drug: Milnacipran

  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

  Other Name: Savella
• Drug: Placebo
  matching placebo tablets daily

Study Arms

• Experimental: Milnacipran
  oral administration, twice daily dosing
  Intervention: Drug: Milnacipran
• Placebo Comparator: Placebo
  oral administration, twice daily dosing
  Intervention: Drug: Placebo

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 23, 2019): 116
• Original Estimated Enrollment (submitted: April 1, 2011): 312
• Actual Study Completion Date: August 31, 2012
• Actual Primary Completion Date: August 31, 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of primary fibromyalgia
• 13-17 years of age
• To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
• To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
• To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
• Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Exclusion Criteria:

• Severe psychiatric illness
• Severe renal impairment
• Evidence of active liver disease
• Pregnant or breastfeeding
• Significant risk of suicidality
• Unable, unwilling or inadvisable to discontinue prohibited medications
• History of alcohol abuse or drug abuse or dependence, within previous year
• Current systemic infection
• Autoimmune disease
• History of seizure disorder (other than febrile seizures)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01328002
• Other Study ID Numbers: MLN-MD-14
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Forest Laboratories
• Original Responsible Party: Stephen M. Graham, PhD, Forest Research Institute
• Current Study Sponsor: Forest Laboratories
• Original Study Sponsor: Same as current
• Collaborators: Cypress Bioscience, Inc.

Investigators

• Study Director: Patricia M D'Astoli, LPN; Forest Laboratories

• PRS Account: Forest Laboratories
• Verification Date: March 2019