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

Forest Laboratories

Status and phase: Terminated; Phase 2

Conditions: Primary Fibromyalgia

Treatments: Drug: Milnacipran

Study type: Interventional

Funder types: Industry

Identifiers

NCT01331109

MLN-MD-29

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 1 patient group

Milnacipran

Experimental group

Description:

oral administration, twice daily dosing

Treatment:

Drug: Milnacipran