Randomised Controlled Trial of Memantine in Fibromyalgia

NCT01653457 | Unknown Phase 3

• 1 other identifier: EC11-387
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Magnetic Resonance Spectroscopy; Memantine; electroencephalic cordance

Outcome Measures

Primary Outcomes (6)

• Change from baseline in pain threshold at month 1

  It will be measured by sphygmomanometry, a clinical test widely used and very efficient to identify patients with fibromyalgia.

  Month 1

• Change from baseline in pain threshold at month 3

  It will be measured by sphygmomanometry, a clinical test widely used and very efficient to identify patients with fibromyalgia. Pain perception will be evaluated with the Pain Visual Analogue Scale (VAS pain). It is a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain and very severe pain)

  Month 3

• Change from baseline in pain threshold at month 6

  It will be measured by sphygmomanometry, a clinical test widely used and very efficient to identify patients with fibromyalgia.

  Month 6

• Change from baseline in pain perception at month 1

  Pain perception will be evaluated with the Pain Visual Analogue Scale (VAS pain). It is a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain and very severe pain)

  Month 1

• Change from baseline in pain perception at month 3

  Pain perception will be evaluated with the Pain Visual Analogue Scale (VAS pain). It is a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain and very severe pain)

  Month 3

• Change from baseline in pain perception at month 6

  Pain perception will be evaluated with the Pain Visual Analogue Scale (VAS pain). It is a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain and very severe pain)

  Month 6

Secondary Outcomes (6)

• To assess improvement in cognitive state

  Baseline, month 1, month 3 and month 6

• To assess improvement in Health Status

  Baseline, month 1, month 3 and month 6

• To assess Anxiety and depression levels

  Baseline, month 1, month 3 and month 6

• To assess Quality of life

  Baseline, month 1, month 3 and month 6

• To assess Clinical Global Impression

  Baseline, month 1, month 3 and month 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Memantine

ACTIVE COMPARATOR

Drug: Memantine

Interventions

Memantine DRUG

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

Also known as: Ebixa

Memantine

Placebo DRUG

Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18 and 65 years.
• Ability to understand Spanish.
• Diagnosis of fibromyalgia carried out by a rheumatologist according to the American College of rheumatology criteria (ACR1990).
• Ability to read and understand the Patient Information Sheet
• Signature of Informed Consent Form.
• In the case of women of childbearing age, commitment not to become pregnant during the entire duration of the study.

You may not qualify if:

• Undergoing drug treatment for fibromyalgia. Patients undergoing treatment for fibromyalgia will stop treatment and perform a washout period of one week. During that week the patient may take, if necessary, analgesic such as paracetamol, ibuprofen and other NSAIDS to minimize the influence of medication on brain imaging.
• Currently taking memantine or having taken memantine during the 2 months prior to recruitment.
• Another Axis I psychiatric disorder using SCID-I that might hinder adherence to the protocol (e.g.: dementia, alcohol and/or substance abuse/dependence, schizophrenia, chronic delirium, acute depression).
• Pregnancy or breast-feeding.
• Hypersensitivity to the active ingredient, memantine, or to the excipients.
• Medical conditions that require special precautions when administering memantine according to the summary of product characteristics:
• Epilepsy.
• 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.
• 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).
• 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.
• Use of non-permitted concomitant medication during the week prior to the first evaluation visit or when 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.)

Sponsors & Collaborators

• Aragon Institute of Health Sciences: lead

Study Sites (1)

Mental Health Unit, Primary Care Center "Torrero".

Zaragoza, Zaragoza, 50007, Spain

Location

Related Publications (31)

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MeSH Terms

Conditions

Fibromyalgia

Interventions

Memantine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• José Javier García Campayo, PhD

  Miguel Servet University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 31, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

ES (1)