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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 Description
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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.

Condition or disease Intervention/treatment Phase
Primary Fibromyalgia Drug: Milnacipran Drug: Placebo Phase 2

Detailed Description:
  • 8 weeks open-label treatment period with milnacipran.
  • Followed by randomization to 8-weeks double blind treatment period for eligible patients
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2011
Actual Primary Completion Date : August 31, 2012
Actual Study Completion Date : August 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Milnacipran
oral administration, twice daily dosing
 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
Placebo Comparator: Placebo
oral administration, twice daily dosing
 Drug: Placebo
matching placebo tablets daily


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328002


Locations
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Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Investigators
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Study Director: Patricia M D'Astoli, LPN Forest Laboratories
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01328002    
Other Study ID Numbers: MLN-MD-14
First Posted: April 4, 2011    Key Record Dates
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019
Last Verified: March 2019
Keywords provided by Forest Laboratories:
Fibromyalgia
Pediatric Fibromyalgia
Adolescent Fibromyalgia
milnacipran
Savella
loss of therapeutic response
 Forest Research Institute
Pain
Fatigue
Serotonin Norepinephrine Reuptake Inhibitors
Randomized Withdrawal
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Levomilnacipran
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs