Randomised Controlled Trial of Memantine in Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Aragon Institute of Health Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier:
NCT01653457
First received: July 6, 2012
Last updated: July 30, 2012
Last verified: July 2012

July 6, 2012
July 30, 2012
September 2012
October 2012   (final data collection date for primary outcome measure)
  • Change from baseline in pain threshold at month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    It will be measured by sphygmomanometry, a clinical test widely used and very efficient to identify patients with fibromyalgia.
  • Change from baseline in pain threshold at month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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)
  • Change from baseline in pain threshold at month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    It will be measured by sphygmomanometry, a clinical test widely used and very efficient to identify patients with fibromyalgia.
  • Change from baseline in pain perception at month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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)
  • Change from baseline in pain perception at month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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)
  • Change from baseline in pain perception at month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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)
Same as current
Complete list of historical versions of study NCT01653457 on ClinicalTrials.gov Archive Site
  • To assess improvement in cognitive state [ Time Frame: Baseline, month 1, month 3 and month 6 ] [ Designated as safety issue: No ]

    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.

  • To assess improvement in Health Status [ Time Frame: Baseline, month 1, month 3 and month 6 ] [ Designated as safety issue: No ]
    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.
  • To assess Anxiety and depression levels [ Time Frame: Baseline, month 1, month 3 and month 6 ] [ Designated as safety issue: No ]
    This will be evaluated with the Hospital Anxiety Depression Scale (HADS).Spanish version will be used.
  • To assess Quality of life [ Time Frame: Baseline, month 1, month 3 and month 6 ] [ Designated as safety issue: No ]
    It will be measured by the EuroQol 5D questionnaire. Spanish version will be used.
  • To assess Clinical Global Impression [ Time Frame: Baseline, month 1, month 3 and month 6 ] [ Designated as safety issue: No ]
    It will be evaluated with the Clinical Global Impression scale.
  • Glutamate levels in different brain regions (insula, hippocampus and posterior cingulate cortex). [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    This will be assessed with magnetic resonance spectroscopy (MRS) and by quantitative encephalography and electroencephalic cordance.
Same as current
Not Provided
Not Provided
 
Randomised Controlled Trial of Memantine in Fibromyalgia
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • 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
  • Drug: Placebo
    Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Memantine
    Intervention: Drug: Memantine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
May 2013
October 2012   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 65 Years
No
Spain
 
NCT01653457
EC11-387
No
Aragon Institute of Health Sciences
Aragon Institute of Health Sciences
Not Provided
Principal Investigator: José Javier García Campayo, PhD Miguel Servet University Hospital
Aragon Institute of Health Sciences
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP