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Trial record 1 of 2 for:    memantine fibromyalgia
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Randomised Controlled Trial of Memantine in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01653457
Recruitment Status : Unknown
Verified July 2012 by Aragon Institute of Health Sciences.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Aragon Institute of Health Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Memantine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Memantine in the Treatment of Fibromyalgia: a Double-blind Randomized Trial
Study Start Date : September 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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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 Name: Ebixa


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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)

  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.

  4. 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)

  5. 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)

  6. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653457


Locations
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Spain
Mental Health Unit, Primary Care Center "Torrero".
Zaragoza, Spain, 50007
Principal Investigator: José Javier García Campayo, PhD         
Sponsors and Collaborators
Aragon Institute of Health Sciences
Investigators
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Principal Investigator: José Javier García Campayo, PhD Miguel Servet University Hospital
More Information
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Publications:

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Responsible Party: Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01653457    
Other Study ID Numbers: EC11-387
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012
Keywords provided by Aragon Institute of Health Sciences:
Fibromyalgia
Magnetic Resonance Spectroscopy
Memantine
electroencephalic cordance
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Memantine
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
 Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents