Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome
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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 |
- 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) |
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 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 May 16, 2013