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Randomised Controlled Trial of Memantine in Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Memantine

Placebo

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Magnetic Resonance Spectroscopy, Memantine, electroencephalic cordance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

6 .In the case of women of childbearing age, commitment not to become pregnant during the entire duration of the study.

Exclusion Criteria:

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.)

Sites / Locations

Mental Health Unit, Primary Care Center "Torrero".

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Memantine

Arm Description

Outcomes

Primary Outcome Measures

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.

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)

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.

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)

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)

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)

Secondary Outcome Measures

To assess improvement in cognitive state

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

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

This will be evaluated with the Hospital Anxiety Depression Scale (HADS).Spanish version will be used.

To assess Quality of life

It will be measured by the EuroQol 5D questionnaire. Spanish version will be used.

To assess Clinical Global Impression

It will be evaluated with the Clinical Global Impression scale.

Glutamate levels in different brain regions (insula, hippocampus and posterior cingulate cortex).

This will be assessed with magnetic resonance spectroscopy (MRS) and by quantitative encephalography and electroencephalic cordance.

Full Information

NCT ID

NCT01653457

First Posted

July 6, 2012

Last Updated

July 30, 2012

Sponsor

Aragon Institute of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01653457

Brief Title

Randomised Controlled Trial of Memantine in Fibromyalgia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aragon Institute of Health Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Magnetic Resonance Spectroscopy, Memantine, electroencephalic cordance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Memantine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Memantine

Other Intervention Name(s)

Ebixa

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in pain threshold at month 1

Description

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

Time Frame

Month 1

Title

Change from baseline in pain threshold at month 3

Description

Time Frame

Month 3

Title

Change from baseline in pain threshold at month 6

Description

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

Time Frame

Month 6

Title

Change from baseline in pain perception at month 1

Description

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)

Time Frame

Month 1

Title

Change from baseline in pain perception at month 3

Description

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)

Time Frame

Month 3

Title

Change from baseline in pain perception at month 6

Description

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)

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

To assess improvement in cognitive state

Description

Time Frame

Baseline, month 1, month 3 and month 6

Title

To assess improvement in Health Status

Description

Time Frame

Baseline, month 1, month 3 and month 6

Title

To assess Anxiety and depression levels

Description

This will be evaluated with the Hospital Anxiety Depression Scale (HADS).Spanish version will be used.

Time Frame

Baseline, month 1, month 3 and month 6

Title

To assess Quality of life

Description

It will be measured by the EuroQol 5D questionnaire. Spanish version will be used.

Time Frame

Baseline, month 1, month 3 and month 6

Title

To assess Clinical Global Impression

Description

It will be evaluated with the Clinical Global Impression scale.

Time Frame

Baseline, month 1, month 3 and month 6

Title

Glutamate levels in different brain regions (insula, hippocampus and posterior cingulate cortex).

Description

This will be assessed with magnetic resonance spectroscopy (MRS) and by quantitative encephalography and electroencephalic cordance.

Time Frame

Baseline, month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 6 .In the case of women of childbearing age, commitment not to become pregnant during the entire duration of the study. Exclusion Criteria: 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Javier García Campayo, PhD

Organizational Affiliation

Miguel Servet University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mental Health Unit, Primary Care Center "Torrero".

City

Zaragoza

ZIP/Postal Code

50007

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Javier García Campayo, PhD

12. IPD Sharing Statement

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Randomised Controlled Trial of Memantine in Fibromyalgia

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