Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Primary Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01328002

Run by

Forest Laboratories

People needed

116

Starts

2011-04-30

Expected to finish

2012-08-31

Last updated by the study team

2019-05-14

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Forest Investigative Site 040 — Birmingham, Alabama, United States
• Forest Investigative Site 068 — Birmingham, Alabama, United States
• Forest Investigative Site 033 — Bullhead City, Arizona, United States
• Forest Investigative Site 012 — Fresno, California, United States
• Forest Investigative Site 045 — Fresno, California, United States
• Forest Investigative Site 051 — Fresno, California, United States
• Forest Investigative Site 035 — Orange, California, United States
• Forest Investigative Site 053 — Orange, California, United States
• Forest Investigative Site 050 — Sacramento, California, United States
• Forest Investigative Site 034 — Colorado Springs, Colorado, United States
• Forest Investigative Site 047 — Cromwell, Connecticut, United States
• Forest Investigative Site 061 — Gainesville, Florida, United States
• Forest Investigative Site 041 — Orange City, Florida, United States
• Forest Investigative Site 059 — Orlando, Florida, United States
• Forest Investigative Site 014 — Spring Hill, Florida, United States
• Forest Investigative Site 055 — West Palm Beach, Florida, United States
• Forest Investigative Site 058 — Blue Ridge, Georgia, United States
• Forest Investigative Site 031 — Savannah, Georgia, United States
• Forest Investigative Site 022 — Chicago, Illinois, United States
• Forest Investigative Site 010 — Peoria, Illinois, United States
• Forest Investigative Site 005 — Indianapolis, Indiana, United States
• Forest Investigative Site 017 — Louisville, Kentucky, United States
• Forest Investigative Site 009 — Ann Arbor, Michigan, United States
• Forest Investigative Site 024 — Rochester Hills, Michigan, United States
• Forest Investigative Site 036 — Stevensville, Michigan, United States

Full record on ClinicalTrials.gov

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