Efficacy of memantine in the treatment of fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia; Musculoskeletal Diseases

• Registration Number: ISRCTN45127327
• Lead Sponsor: Aragon Institute of Health Sciences (Instituto Aragonés de Ciencias de la Salud) (IACS) (Spain)

Brief Summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23286311 2. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/25218600 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-03
• Study Completion: 2013-05-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Improvement in clinical variables:<br> 1. Pain threshold<br> 2. Pain perception<br> 3. Cognitive state<br> 4. Health status<br> 5. State of anxiety and depression<br> 6. Quality of life and<br> 7. Perceived improvement<br>

Secondary Outcome Measures

Name	Time	Method
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).