Randomised Controlled Trial of Memantine in Fibromyalgia
NCT ID: NCT01653457
Last Updated: 2012-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2012-09-30
2013-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.
Memantine
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
Interventions
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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
Placebo
Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.)
18 Years
65 Years
ALL
No
Sponsors
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Aragon Institute of Health Sciences
OTHER
Responsible Party
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Principal Investigators
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José Javier García Campayo, PhD
Role: PRINCIPAL_INVESTIGATOR
Miguel Servet University Hospital
Locations
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Mental Health Unit, Primary Care Center "Torrero".
Zaragoza, Zaragoza, Spain
Countries
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References
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Other Identifiers
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EC11-387
Identifier Type: -
Identifier Source: org_study_id