Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

• Status: Terminated
• Trial end date: 2012-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Cypress Bioscience, Inc.
• Treatments: Levomilnacipran; Milnacipran

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)