Fibromyalgia Clinical Trial
Official title:
Efficacy of Memantine in the Treatment of Fibromyalgia: a Double-blind Randomized Trial
Fibromyalgia (FM) is a chronic rheumatic disease of high prevalence and great clinical
impact. However, the treatment for FM has limited efficacy, with an effect size of about
0.5. Recent studies have found raised levels of glutamate in the insula, hippocampus and
posterior cingulate cortex regions of the brain. This has led a number of authors to suggest
the usefulness of glutamate blocking drugs in the treatment of FM.
Aims: To evaluate the efficacy of memantine in the treatment of pain and other symptoms of
FM and to assess its efficacy in reducing brain glutamate levels in patients with FM.
Material and methods: Randomized controlled trial, of six months duration (including a dose
adjustment period of one month). 60 patients with FM will be recruited for inclusion in the
study upon fulfillment of selection criteria, and they will be randomized in two groups: A)
Treatment group (n=30), will receive 20 mg of memantine o.d ; B) Control group (n=30) will
receive placebo. The main objective is to assess the efficacy of memantine in the treatment
of pain (pain threshold, pain perception) and other symptoms in fibromyalgia (cognitive
state, health status, state of anxiety and depression, quality of life and perceived
improvement. Discussion: There is a need for the development of innovative and more
effective alternatives for the treatment of FM. This clinical trial will determine whether
memantine can be considered as an option in the treatment of FM patients.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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