Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

This study has been withdrawn prior to enrollment.
(The FDA IND application is paused due to additional required testing. The IRB protocol was closed prior to research starting.)
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00855972
First received: March 3, 2009
Last updated: December 14, 2010
Last verified: December 2010

March 3, 2009
December 14, 2010
August 2010
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Self-reported Pain
  • Self-reported Fatigue
  • Overall Fibromyalgia Symptom report
Complete list of historical versions of study NCT00855972 on ClinicalTrials.gov 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.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Drug: Low Dose Naltrexone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
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

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00855972
SU-03022009-1918, 15979
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Sean Mackey, Stanford University School of Medicine
Stanford University
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Sub-Investigator: Jarred Younger Stanford University
Principal Investigator: Sean Mackey Stanford University
Stanford University
December 2010

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