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Efficacy of memantine in the treatment of fibromyalgia
ISRCTN ISRCTN45127327
DOI 10.1186/ISRCTN45127327
ClinicalTrials.gov identifier
EudraCT number 2011-006244-73
Public title Efficacy of memantine in the treatment of fibromyalgia
Scientific title Efficacy of memantine in the treatment of fibromyalgia: a double-blind randomised controlled trial
Acronym NAP
Serial number at source EC11-387
Study hypothesis Recent studies have demonstrated elevated levels of glutamate in different brain areas such as insula, hippocampus and posterior cingulate cortex in patients with fibromyalgia, suggesting the possibility of using N-Methyl-D-Aspartate Receptor (NMDAR) antagonist such as memantine in the treatment of this disorder. NMDAR antagonists possess significant pain-reducing and neuroprotective properties and are widely used in clinical practice. Dextromethorphan and ketamine have shown particular pain-reducing efficacy in fibromyalgia syndrome (FMS), although their use as longitudinal treatments is limited. New research has highlighted memantine’s effectiveness in the treatment of complex regional pain syndrome and phantom limb pain, suggesting that its quality of pain reduction is dependent on the type of pain being treated. Memantine exhibited an extremely low incidence of side effects in human clinical trials, and a recent trial extension demonstrated the drug’s clinical tolerability even with prolonged use.

No effective treatments for fibromyalgia have been described. This is the first pharmacological treatment for fibromyalgia based on the physiopathology of the disorder. Previous preliminary studies of our group with memantine showed significant improvements in cognitive function, depression and global clinical impression.
Lay summary Lay summary under review 3
Ethics approval Ethics Committee in Aragon (CEICA), 06 March 2012
Study design Unicentric double-blind randomised trial
Countries of recruitment Spain
Disease/condition/study domain Fibromyalgia
Participants - inclusion criteria 1. Male or female aged between 18 and 65 years
2. Ability to understand Spanish
3. Diagnosis of fibromyalgia carried out by a rheumatologist according to the American College of rheumatology criteria (ACR1990)
4. Ability to read and understand the Patient Information Sheet
5. Signature of Informed Consent Form
6. In the case of women of childbearing age, commitment not to become pregnant during the entire duration of the study
Participants - exclusion criteria 1. Undergoing drug treatment for fibromyalgia. Patients in current treatment for fibromyalgia will stop treatment and perform a washout period of one week. During that week the patient may take, if necessary, analgesics such as tramadol or paracetamol to minimise the influence of medication on brain imaging.
2. Currently taking memantine or having taken memantine during the 2 months prior to recruitment
3. Another Axis I psychiatric disorder using Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) that might hinder adherence to the protocol (e.g.: dementia, alcohol and/or substance abuse/dependence, schizophrenia, chronic delirium, acute depression)
4. Pregnancy or breast-feeding
5. Hypersensitivity to the active ingredient, memantine, or to the excipients
6. Medical conditions that require special precautions when administering memantine according to the summary of product characteristics:
6.1. Epilepsy
6.2. Circumstances that may cause high urine pH owing to Proteus urinary infection, renal tubular acidosis or vegetarian diet, recent myocardial infarction, congestive heart disease and uncontrolled arterial hypertension
7. Clinically significant and active evidence of liver or kidney disease, haematological, respiratory, endocrine or cardiovascular disease or disorders (patients with controlled diabetes and patients with controlled hypertension and complete or incomplete right bundle branch block can be included in the study)
8. Use of prescription drugs that may cause relevant drug interactions with memantine according to the summary of product characteristics: NMDAR antagonists (amantadine, ketamine, dextromethorphan), L-Dopa, dopamine agonists and cholinergic agonists.
9. Use of non-permitted concomitant medication during the week prior to the first evaluation visit or where the patient is expected to require treatment (with at least one of the drugs not permitted during the study): antidepressants (duloxetine, venlafaxine, mirtazapine, bupropion, SSRI, etc.), analgesics (pregabalin, gabapentin, opiates, etc.)
Anticipated start date 01/09/2012
Anticipated end date 31/05/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions Sample size for this study is 60 subjects recruited in the Mental Health Unit-Primary Care Center "Torrero" in Zaragoza. Patients will be randomly assigned to one of this groups:

Treatment group. Patients allocated to this group will receive 20 mg memantine daily (2 tables of 10 mg each)

Control group. Patients in this group will receive placebo.

The dose of 20 mg 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
Primary outcome measure(s) Improvement in clinical variables:
1. Pain threshold
2. Pain perception
3. Cognitive state
4. Health status
5. State of anxiety and depression
6. Quality of life and
7. Perceived improvement
Secondary outcome measure(s) Glutamate levels in different brain regions (insula, hippocampus and posterior cingulate cortex) assessed by Magnetic Resonance Spectroscopy (MRS) and by Quantitative Encephalography and Electroencephalic Cordance on a subsample of 30 subjects (15 from the control group and 15 from the treatment group).
Sources of funding Ministry of Health, Social Policy and Equality (Spain)
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23286311
Contact name Dr  José Javier  García Campayo
  Address Department of Psychiatry
Miguel Servet University Hospital & University of Zaragoza
Isabel La Católica, 1
  City/town Zaragoza
  Zip/Postcode 50009
  Country Spain
Sponsor Aragon Institute of Health Sciences (Instituto Aragonés de Ciencias de la Salud) (IACS) (Spain)
  Address San Juan Bosco, 13
  City/town Zaragoza
  Zip/Postcode 50009
  Country Spain
  Sponsor website: http://www.iacs.aragon.es/awgc/
Date applied 25/06/2012
Last edited 07/01/2013
Date ISRCTN assigned 03/08/2012
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