Consultant Karin Bruun Plesner Department of Anesthesiology, OUH Svendborg
Projektet i tal
OPEN undersøgelse/kliniske data
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Inkluderet antal deltagere
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Fibromyalgia and Naltrexone: The FINAL study
A parallel, randomized, double-blinded, placebo controlled clinical trial investigating if low dose naltrexone (LDN) is superior to placebo in reducing pain and improving pain sensitivity in patients with fibromyalgia. As secondary outcomes a possible effect on other fibromyalgia symptoms will be explored. As explorative outcomes changes in muscular exhaustion and physical fitness will be investigated. Blood will be collected for a biobank with the purpose of measuring possible changes in inflammatory cytochines during the treatment.
The use of Low Dose Naltrexone (LDN) as off-label treatment of pain is increasing in Denmark despite very sparse evidense. Regarding the effect of LDN on pain only 2 small clinical trials have been published. In both studies the effect of 4.5 mg LDN was tested against placebo. The first study was a single blinded pilot study including 10 women with fibromyalgia. The second study was a double-blinded randomized trial with a cross-over design including 31 women with fibromyalgia. Both studies showed LDN to be superior to placebo in reducing pain. A small clinical trial including 12 women with fibromyalgia has shown a significant reduction in inflammatory cytochines after 12 weeks of treatment med LDN.
Our study group has carried out a dose-respons study (publication under review) including 25 women with fibromyalgia. We estimated the effective dose in 95 % (ED95) to be 5,4 mg LDN. We found that doses up to 6 mg was well tolerated.
This study is the first larger parallel randomized, double-blinded, placebo controlled study to investigate if LDN is superior til placebo in reducing pain in patients with fibromyalgia. Patients will be titrated up to 6 mg, but if there is problems with tolerability they can be maintained at a lower dose. The treatment period is 12 weeks, including a 4 week titration phase.
Description of the cohort
Women aged 18-64 years with a diagnosis of fibromyalgia.
Data and biological material
Muscle exhaustion test - physical fitness tests.
Pain sensitivity tests.
Collaborating researchers and departments
Department of Anesthesiology and Intensive Care, Odense University Hospital
Consultant, Karin Bruun Plesner
Professor Palle Toft, PhD, Dr. Med.
Consultant Karin Bruun Plesner, PhD student
M.Sc. Henrik Bjarke Vaegter, PhD, Post. doc.
Consultant Morten-Rune Blichfeldt-Eckhardt, PhD, Post. doc.
Department of Rheumatology, Frederiksberg Hospital
Consultant Kirstine Amris, Dr. Med
Department of Orthopedics and Traumatology, Odense University Hospital
M.Sc. Anders Holsgaard Larsen, PhD, Associate Professor
Publications associated with the project
Information about the trial is published at ClinicalTrials.gov and EUDRACT.
The protocol will be published in an international peer-reviewed journal.
Results from the study is planned to be published in international peer-reviewed journals. Both positive, negative and inconclusive results will be published.