Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety and efficacy 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:

• Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

Exclusion Criteria:

• Can not tolerate a minimum daily dose of 50mg milnacipran

• Significant risk of suicidality

• Pregnant or breastfeeding