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| Sponsor: | 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 |
| 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 |
| 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) |
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 |
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| Contact: Jarred Younger | snapl@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Sub-Investigator: | Jarred Younger | Stanford University |
| Principal Investigator: | Sean Mackey | Stanford University |
More Information
| Responsible Party: | Stanford University School of Medicine ( Sean Mackey ) |
| Study ID Numbers: | SU-03022009-1918, 15979 |
| Study First Received: | March 3, 2009 |
| Last Updated: | January 14, 2010 |
| ClinicalTrials.gov Identifier: | NCT00855972 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Disease Fibromyalgia Myofascial Pain Syndromes Nervous System Diseases Narcotic Antagonists Physiological Effects of Drugs Rheumatic Diseases Pharmacologic Actions Muscular Diseases |
Pathologic Processes Musculoskeletal Diseases Neuromuscular Diseases Sensory System Agents Therapeutic Uses Syndrome Naltrexone Peripheral Nervous System Agents Central Nervous System Agents |
