NCT01653457

Randomised Controlled Trial of Memantine in Fibromyalgia

Efficacy of Memantine in the Treatment of Fibromyalgia: a Double-blind Randomized Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aragon Institute of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Memantine	Patients randomised to this arm will receive memantine 20 mg daily. This dose will be reached following this schema: * 1st week: 5 mg daily * 2nd week: 10 mg daily * 3rd week: 15 mg daily * From 4th week up to 24th week: 20 mg daily
DRUG	Placebo	Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2013-05-01
• First posted: 2012-07-31
• Last updated: 2012-07-31

Locations

1 site across 1 country: Spain