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This study has been withdrawn prior to enrollment.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
  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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
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: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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: Sean Mackey, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00855972     History of Changes
Other Study ID Numbers: SU-03022009-1918, 15979
Study First Received: March 3, 2009
Last Updated: December 14, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014