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Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:
Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

Clinical Trial Summary

The purpose of this research is to obtain data or information on the safety and effectiveness of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile fibromyalgia, and at what dose it does so.

Clinical Trial Description

In this pilot dosage-finding and efficacy study, we will experimentally test whether LDN reduces the symptoms of JPFS. We will recruit 40 children with JPFS. Participants will be screened via the JPFS criteria of Yunus and Masi. The study will be an open-label test of various doses of LDN to determine whether LDN reduces JPFS symptoms, and the appropriate dose at which it does so. Primary endpoints will be daily pain, fatigue, and sleep.

The protocol is designed to take 18 weeks. There are a total of 10 study visits, taking place approximately every 2 weeks. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00855972
Study type Interventional
Source Stanford University
Contact
Status Withdrawn
Phase N/A
Start date August 2010
Completion date December 2011
View Details
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