Randomised Controlled Trial of Memantine in Fibromyalgia
Status:
Unknown status
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
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.