Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)
This study has been terminated.
Sponsor:
Forest Laboratories
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01328002
First received: March 31, 2011
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Primary Fibromyalgia Syndrome |
Drug: Milnacipran Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Time to loss of therapeutic response (LTR) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient Global Impression of Severity (PGIS) [ Time Frame: At every visit after Randomization (Visit 7) during the 8 week randomized treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 118 |
| Study Start Date: | April 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Milnacipran
oral administration, twice daily dosing
|
Drug: Milnacipran
Maximum tolerated dose (50, 75, or 100 mg/day tablets) determined at start of study; for 8 weeks
Other Name: Savella
|
|
Placebo Comparator: Placebo
oral administration, twice daily dosing
|
Drug: Placebo
matching placebo tablets daily
|
Detailed Description:
- 8 weeks open-label milnacipran period
- Followed by randomization to 8-weeks double blind treatment period for eligible patients
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of primary fibromyalgia
- 13-17 years of age
Exclusion Criteria:
- Severe psychiatric illness
- Severe renal impairment
- Evidence of active liver disease
- Pregnant or breastfeeding
- Significant risk of suicidality
- Unable, unwilling or unadvisable to discontinue prohibited medications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328002
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| United States, Alabama | |
| Forest Investigative Site 040 | |
| Birmingham, Alabama, United States, 35205 | |
| United States, California | |
| Forest Investigative Site 012 | |
| Fresno, California, United States, 93710 | |
| Forest Investigative Site 045 | |
| Fresno, California, United States, 93720 | |
| Forest Investigative Site 051 | |
| Fresno, California, United States, 93721 | |
| Forest Investigative Site 053 | |
| Orange, California, United States, 92868 | |
| Forest Investigative Site 035 | |
| Orange, California, United States, 92868 | |
| Forest Investigative Site 050 | |
| Sacramento, California, United States, 95825 | |
| United States, Colorado | |
| Forest Investigative Site 034 | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Connecticut | |
| Forest Investigative Site 047 | |
| Cromwell, Connecticut, United States, 06416 | |
| United States, Florida | |
| Forest Investigative Site 041 | |
| Orange City, Florida, United States, 32763 | |
| Forest Investigative Site 061 | |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 014 | |
| Spring Hill, Florida, United States, 34609 | |
| Forest Investigative Site 055 | |
| West Palm Beach, Florida, United States, 33409 | |
| United States, Georgia | |
| Forest Investigative Site 058 | |
| Blue Ridge, Georgia, United States, 30513 | |
| Forest Investigative Site 031 | |
| Savannah, Georgia, United States, 31406 | |
| United States, Illinois | |
| Forest Investigative Site 010 | |
| Peoria, Illinois, United States, 61614 | |
| United States, Kentucky | |
| Forest Investigative Site 017 | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Forest Investigative Site 009 | |
| Ann Arbor, Michigan, United States, 48104 | |
| Forest Investigative Site 036 | |
| Stevensville, Michigan, United States, 49127 | |
| United States, New Jersey | |
| Forest Investigative Site 049 | |
| Whitehouse Station, New Jersey, United States, 08889 | |
| United States, North Carolina | |
| Forest Investigative Site 062 | |
| Raleigh, North Carolina, United States, 27612 | |
| Forest Investigative Site 052 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Forest Investigative Site 038 | |
| Akron, Ohio, United States, 44308 | |
| Forest Investigative Site 016 | |
| Cincinnati, Ohio, United States, 45219 | |
| Forest Investigative Site 015 | |
| Dayton, Ohio, United States, 45432 | |
| United States, Oklahoma | |
| Forest Investigative Site 001 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Forest Investigative Site 027 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Forest Investigative Site 066 | |
| Mechanicsburg, Pennsylvania, United States, 17055 | |
| Forest Investigative Site 054 | |
| Philadelphia, Pennsylvania, United States, 08046 | |
| United States, South Carolina | |
| Forest Investigative Site 046 | |
| Greer, South Carolina, United States, 29651 | |
| United States, Texas | |
| Forest Investigative Site 003 | |
| San Antonio, Texas, United States, 78215 | |
| Forest Investigative Site 042 | |
| San Antonio, Texas, United States, 78258 | |
| United States, Utah | |
| Forest Investigative Site 025 | |
| Clinton, Utah, United States, 84015 | |
| Forest Investigative Site 013 | |
| Salt Lake City, Utah, United States, 84102 | |
| United States, Wisconsin | |
| Forest Investigative Site 004 | |
| Racine, Wisconsin, United States, 53406 | |
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Investigators
| Study Director: | Patricia M D'Astoli, LPN | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01328002 History of Changes |
| Other Study ID Numbers: | MLN-MD-14 |
| Study First Received: | March 31, 2011 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Milnacipran Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 21, 2013