Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

This study is not yet open for participant recruitment.

Verified by Stanford University, March 2009

First Received: March 3, 2009 Last Updated: March 4, 2009 History of Changes

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00855972

Purpose

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.

Condition	Intervention
Fibromyalgia	Drug: Low Dose Naltrexone

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

Further study details as provided by Stanford University:

Primary Outcome Measures:

Self-reported Pain
Self-reported Fatigue
Overall Fibromyalgia Symptom report

Estimated Enrollment:	40
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Generalized musculoskeletal aching for over 3 months duration
Moderate-severe pain in 5 of 11 tender points
Age 7 - 17
Male or female

Exclusion Criteria:

Diagnosed rheumatic or autoimmune condition contributing to pain
Abnormal laboratory results (Rf, ANA, ESR)
Use of opioid analgesics in the last 6 months
Severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening.
Current or previous psychiatric disorder requiring hospitalization
Inability to operate Palm OS® handheld device for self-reports
Inability to understand English
Inability to attend sessions at Stanford lab every 3 weeks
Pregnancy or planned pregnancy, or breastfeeding
Abnormal liver functioning tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855972

Contacts

Contact: Jarred Younger

Jyounger@stanford.edu

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Sub-Investigator:	Jarred Younger	Stanford University
Principal Investigator:	Sean Mackey	Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Jarred Younger )
Study ID Numbers:	SU-03022009-1918, 15979
Study First Received:	March 3, 2009
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00855972 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Narcotic Antagonists

Naltrexone
Narcotics
Pain
Peripheral Nervous System Agents
Rheumatic Diseases

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Nervous System Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Rheumatic Diseases
Pharmacologic Actions
Muscular Diseases

Musculoskeletal Diseases
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Naltrexone
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009