Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome|
- Self Reported Pain [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Self-reported fatigue [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Overall Fibromyalgia Symptom report [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.