Randomised Controlled Trial of Memantine in Fibromyalgia

July 30, 2012 updated by: Aragon Institute of Health Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50007
        • Mental Health Unit, Primary Care Center "Torrero".
        • Principal Investigator:
          • José Javier García Campayo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.
  2. Currently taking memantine or having taken memantine during the 2 months prior to recruitment.
  3. 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).
  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:

    • 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.
  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 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.
Active Comparator: Memantine
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
Other Names:
  • Ebixa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain threshold at month 1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess improvement in cognitive state
Time Frame: Baseline, month 1, month 3 and month 6

It will be measured by the Cognition Mini-Exam (MEC).In people under 65 years old, like the population in our study, the threshold that suggests a "probable case" is <27 points. The Spanish version of the questionnaire will be used.

Cognitive state will also be measured by qEEG event-related desynchronization (ERD) at absolute power of upper alpha rhythms in the parieto-occipital region while cognitive tasks are performed.
Baseline, month 1, month 3 and month 6
To assess improvement in Health Status
Time Frame: Baseline, month 1, month 3 and month 6
It will be evaluated with the Fibromyalgia Impact Questionnaire (FIQ). FIQ is a 10-Item self-questionnaire to measure the Health Status in patients with fibromyalgia. The Spanish version will be used.
Baseline, month 1, month 3 and month 6
To assess Anxiety and depression levels
Time Frame: Baseline, month 1, month 3 and month 6
This will be evaluated with the Hospital Anxiety Depression Scale (HADS).Spanish version will be used.
Baseline, month 1, month 3 and month 6
To assess Quality of life
Time Frame: Baseline, month 1, month 3 and month 6
It will be measured by the EuroQol 5D questionnaire. Spanish version will be used.
Baseline, month 1, month 3 and month 6
To assess Clinical Global Impression
Time Frame: Baseline, month 1, month 3 and month 6
It will be evaluated with the Clinical Global Impression scale.
Baseline, month 1, month 3 and month 6
Glutamate levels in different brain regions (insula, hippocampus and posterior cingulate cortex).
Time Frame: Baseline, month 6
This will be assessed with magnetic resonance spectroscopy (MRS) and by quantitative encephalography and electroencephalic cordance.
Baseline, month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aragon Institute of Health Sciences

Investigators

  • Principal Investigator: José Javier García Campayo, PhD, Miguel Servet University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC11-387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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