FibromyalgiaPhase 3NCT01653457
Randomised Controlled Trial of Memantine in Fibromyalgia
A Phase 3 study testing Memantine in people with Fibromyalgia, run by Aragon Institute of Health Sciences at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Mental Health Unit, Primary Care Center "Torrero".
Zaragoza, Zaragoza, 50007
José Javier García Campayo, PhD
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Memantine, Placebo
- Keywords
- Fibromyalgia, Magnetic Resonance Spectroscopy, Memantine, electroencephalic cordance
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Ebixa
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
PlaceboDrug
Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Memantine | Active comparator | Not described Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 1
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)
Measured: Month 3
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.
Measured: Month 6
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)
Measured: Month 1
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)
Measured: Month 3
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)
Measured: Month 6
Secondary outcomes (6)
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.
Measured: Baseline, month 1, month 3 and month 6
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.
Measured: Baseline, month 1, month 3 and month 6
To assess Anxiety and depression levels
This will be evaluated with the Hospital Anxiety Depression Scale (HADS).Spanish version will be used.
Measured: Baseline, month 1, month 3 and month 6
To assess Quality of life
It will be measured by the EuroQol 5D questionnaire. Spanish version will be used.
Measured: Baseline, month 1, month 3 and month 6
To assess Clinical Global Impression
It will be evaluated with the Clinical Global Impression scale.
Measured: Baseline, month 1, month 3 and month 6
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.
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aragon Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Javier García Campayo, PhD, Principal investigator, Miguel Servet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653457
- Sponsor's protocol ID
- EC11-387
- Status last verified
- Jul 2012
- First submitted
- 6 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Staud R, Vierck CJ, Robinson ME, Price DD. Effects of the N-methyl-D-aspartate receptor antagonist dextromethorphan on temporal summation of pain are similar in fibromyalgia patients and normal control subjects. J Pain. 2005 May;6(5):323-32. doi: 10.1016/j.jpain.2005.01.357.
PubMed 15890634Graven-Nielsen T, Kendall SA, Henriksson KG, Bengtsson M, Sorensen J, Johnson A, Gerdle B, Arendt-Nielsen L. Ketamine reduces muscle pain, temporal summation, and referred pain in fibromyalgia patients. Pain. 2000 Apr;85(3):483-491. doi: 10.1016/S0304-3959(99)00308-5.
PubMed 10781923Chen HS, Lipton SA. The chemical biology of clinically tolerated NMDA receptor antagonists. J Neurochem. 2006 Jun;97(6):1611-26. doi: 10.1111/j.1471-4159.2006.03991.x.
PubMed 16805772Tariot PN, Farlow MR, Grossberg GT, Graham SM, McDonald S, Gergel I; Memantine Study Group. Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial. JAMA. 2004 Jan 21;291(3):317-24. doi: 10.1001/jama.291.3.317.
PubMed 14734594Reisberg B, Doody R, Stoffler A, Schmitt F, Ferris S, Mobius HJ. A 24-week open-label extension study of memantine in moderate to severe Alzheimer disease. Arch Neurol. 2006 Jan;63(1):49-54. doi: 10.1001/archneur.63.1.49.
PubMed 16401736Nikolajsen L, Gottrup H, Kristensen AG, Jensen TS. Memantine (a N-methyl-D-aspartate receptor antagonist) in the treatment of neuropathic pain after amputation or surgery: a randomized, double-blinded, cross-over study. Anesth Analg. 2000 Oct;91(4):960-6. doi: 10.1097/00000539-200010000-00036.
PubMed 11004057Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.
PubMed 10875724Sinis N, Birbaumer N, Gustin S, Schwarz A, Bredanger S, Becker ST, Unertl K, Schaller HE, Haerle M. Memantine treatment of complex regional pain syndrome: a preliminary report of six cases. Clin J Pain. 2007 Mar-Apr;23(3):237-43. doi: 10.1097/AJP.0b013e31802f67a7.
PubMed 17314583Hackworth RJ, Tokarz KA, Fowler IM, Wallace SC, Stedje-Larsen ET. Profound pain reduction after induction of memantine treatment in two patients with severe phantom limb pain. Anesth Analg. 2008 Oct;107(4):1377-9. doi: 10.1213/ane.0b013e31817f90f1.
PubMed 18806054Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
PubMed 2306288Gamero Ruiz F, Gabriel Sanchez R, Carbonell Abello J, Tornero Molina J, Sanchez-Magro I. [Pain in Spanish rheumatology outpatient offices: EPIDOR epidemiological study]. Rev Clin Esp. 2005 Apr;205(4):157-63. doi: 10.1157/13074161. Spanish.
PubMed 15860186Briley M. Drugs to treat fibromyalgia - the transatlantic difference. Curr Opin Investig Drugs. 2010 Jan;11(1):16-8.
PubMed 20047155Garcia-Campayo J, Magdalena J, Magallon R, Fernandez-Garcia E, Salas M, Andres E. A meta-analysis of the efficacy of fibromyalgia treatment according to level of care. Arthritis Res Ther. 2008;10(4):R81. doi: 10.1186/ar2455. Epub 2008 Jul 15.
PubMed 18627602Mountz JM, Bradley LA, Modell JG, Alexander RW, Triana-Alexander M, Aaron LA, Stewart KE, Alarcon GS, Mountz JD. Fibromyalgia in women. Abnormalities of regional cerebral blood flow in the thalamus and the caudate nucleus are associated with low pain threshold levels. Arthritis Rheum. 1995 Jul;38(7):926-38. doi: 10.1002/art.1780380708.
PubMed 7612042Kwiatek R, Barnden L, Tedman R, Jarrett R, Chew J, Rowe C, Pile K. Regional cerebral blood flow in fibromyalgia: single-photon-emission computed tomography evidence of reduction in the pontine tegmentum and thalami. Arthritis Rheum. 2000 Dec;43(12):2823-33. doi: 10.1002/1529-0131(200012)43:123.0.CO;2-E.
PubMed 11145042
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Memantine in the Treatment of Fibromyalgia: a Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT01653457
- Acronym / sponsor ID
- EC11-387
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Magnetic Resonance Spectroscopy, Memantine, electroencephalic cordance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aragon Institute of Health SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Memantine | Active comparator | Drug: Memantine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: EbixaPatients 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 | Drug | Memantine |
| PlaceboPatients randomised to this group will receive film-coated placebo tablets (similar to drug tablets. | Drug | Placebo |
Primary outcome
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.
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)
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.
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)
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)
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)
6 secondary outcomes
To assess improvement in cognitive state
Time frame: Baseline, month 1, month 3 and month 6
To assess improvement in Health Status
Time frame: Baseline, month 1, month 3 and month 6
To assess Anxiety and depression levels
Time frame: Baseline, month 1, month 3 and month 6
To assess Quality of life
Time frame: Baseline, month 1, month 3 and month 6
To assess Clinical Global Impression
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Background: PubMed 15890634Staud R, Vierck CJ, Robinson ME, Price DD. Effects of the N-methyl-D-aspartate receptor antagonist dextromethorphan on temporal summation of pain are similar in fibromyalgia patients and normal control subjects. J Pain. 2005 May;6(5):323-32. doi: 10.1016/j.jpain.2005.01.357.
- Background: PubMed 10781923Graven-Nielsen T, Kendall SA, Henriksson KG, Bengtsson M, Sorensen J, Johnson A, Gerdle B, Arendt-Nielsen L. Ketamine reduces muscle pain, temporal summation, and referred pain in fibromyalgia patients. Pain. 2000 Apr;85(3):483-491. doi: 10.1016/S0304-3959(99)00308-5.
- Background: PubMed 16805772Chen HS, Lipton SA. The chemical biology of clinically tolerated NMDA receptor antagonists. J Neurochem. 2006 Jun;97(6):1611-26. doi: 10.1111/j.1471-4159.2006.03991.x.
- Background: PubMed 14734594Tariot PN, Farlow MR, Grossberg GT, Graham SM, McDonald S, Gergel I; Memantine Study Group. Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial. JAMA. 2004 Jan 21;291(3):317-24. doi: 10.1001/jama.291.3.317.
- Background: PubMed 16401736Reisberg B, Doody R, Stoffler A, Schmitt F, Ferris S, Mobius HJ. A 24-week open-label extension study of memantine in moderate to severe Alzheimer disease. Arch Neurol. 2006 Jan;63(1):49-54. doi: 10.1001/archneur.63.1.49.
- Background: PubMed 11004057Nikolajsen L, Gottrup H, Kristensen AG, Jensen TS. Memantine (a N-methyl-D-aspartate receptor antagonist) in the treatment of neuropathic pain after amputation or surgery: a randomized, double-blinded, cross-over study. Anesth Analg. 2000 Oct;91(4):960-6. doi: 10.1097/00000539-200010000-00036.
- Background: PubMed 10875724Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.
- Background: PubMed 17314583Sinis N, Birbaumer N, Gustin S, Schwarz A, Bredanger S, Becker ST, Unertl K, Schaller HE, Haerle M. Memantine treatment of complex regional pain syndrome: a preliminary report of six cases. Clin J Pain. 2007 Mar-Apr;23(3):237-43. doi: 10.1097/AJP.0b013e31802f67a7.
- Background: PubMed 18806054Hackworth RJ, Tokarz KA, Fowler IM, Wallace SC, Stedje-Larsen ET. Profound pain reduction after induction of memantine treatment in two patients with severe phantom limb pain. Anesth Analg. 2008 Oct;107(4):1377-9. doi: 10.1213/ane.0b013e31817f90f1.
- Background: PubMed 2306288Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
- Background: PubMed 15860186Gamero Ruiz F, Gabriel Sanchez R, Carbonell Abello J, Tornero Molina J, Sanchez-Magro I. [Pain in Spanish rheumatology outpatient offices: EPIDOR epidemiological study]. Rev Clin Esp. 2005 Apr;205(4):157-63. doi: 10.1157/13074161. Spanish.
- Background: PubMed 20047155Briley M. Drugs to treat fibromyalgia - the transatlantic difference. Curr Opin Investig Drugs. 2010 Jan;11(1):16-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Javier García Campayo, PhD principal investigator
Miguel Servet University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memantine in people with Fibromyalgia, run by Aragon Institute of Health Sciences at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain threshold at month 1 (time frame: Month 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653457, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.