Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855972
Recruitment Status : Withdrawn (The FDA IND application is paused due to additional required testing. The IRB protocol was closed prior to research starting.)
First Posted : March 5, 2009
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Sean Mackey, Stanford University

March 3, 2009
March 5, 2009
December 11, 2015
August 2010
December 2011   (Final data collection date for primary outcome measure)
  • Self Reported Pain [ Time Frame: duration of trial ]
  • Self-reported fatigue [ Time Frame: duration of trial ]
  • Overall Fibromyalgia Symptom report [ Time Frame: duration of trial ]
  • Self Reported Pain
  • Self-reported fatigue
  • Overall Fibromyalgia Symptom report
Complete list of historical versions of study NCT00855972 on Archive Site
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Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome
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.

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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Low Dose Naltrexone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:1. Generalized musculoskeletal aching for over 3 months duration 2. Moderate-severe pain in 5 of 11 tender points 3. Age 7 - 17 4. Male or female

Exclusion Criteria:1. Diagnosed rheumatic or autoimmune condition contributing to pain 2. Abnormal laboratory results (Rf, ANA, ESR) 3. Use of opioid analgesics in the last 6 months 4. 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. 5. Current or previous psychiatric disorder requiring hospitalization 6. Inability to operate Palm OS® handheld device for self-reports 7. Inability to understand English 8. Inability to attend sessions at Stanford lab every 3 weeks 9. Pregnancy or planned pregnancy, or breastfeeding 10. Abnormal liver functioning tests

Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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United States
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Sean Mackey, Stanford University
Stanford University
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Sub-Investigator: Jarred Younger Stanford University
Principal Investigator: Sean Mackey Stanford University
Stanford University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP