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

Phase 2TerminatedNCT01331109

Forest Laboratories57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Fibromyalgia

Interventions

MilnacipranDRUG

maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

Adverse Events

Number of Patients who experience one or more treatment emergent adverse event (TEAE)

Time frame: Baseline (Visit 1) to Week 53 (Visit 9)

Data from ClinicalTrials.gov

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Forest Investigative Site 040

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 014

Spring Hill, Florida, United States

...and 21 more locations