FibromyalgiaPhase 2/3NCT04502251
LDN and tDCS in Fibromyalgia
A Phase 2/3 study testing Low-Dose Naltrexone and Transcranial Direct Current Stimulation in people with Fibromyalgia, run by Centro Universitario La Salle at 1 site in Brazil.
Trial summary
Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 8 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Low-Dose Naltrexone and Transcranial Direct Current Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 1 Jul 2020
- Phase
- Phase 2/3
- 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 8 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- signed the consent form
- women from 18 to 65 years
- confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria
- read and write
- pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months
- chronic stable treatment in the last 3 months.
Who cannot join
- in use of opioid drugs;
- pregnancy or not using anticontraceptive
- history of alcohol or drug abuse in the last 6 months
- history of neurological pathologies
- history of arrhythmia
- history of use of drugs that might change vascular response
Show all 11Show fewer
- history of head trauma
- history of neurosurgery
- decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)
- history of non-compensated hypothyroidism
- personal history of cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia: Randomized Clinical Trial, Blind, Controlled With Placebo
Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current Stimulation (tDCS), have been shown effective for pain management. This study aims to evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in fibromyalgia patients. This is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. Patients will be allocated into 4 groups: tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic Factor (BDNF) serum levels.
- Conditions
- Fibromyalgia
- Being tested
- Low-Dose Naltrexone, Transcranial Direct Current Stimulation, Placebo, Sham Transcranial Direct Current Stimulation
- Keywords
- tDCS, LDN, Transcranial Direct Current Stimulation, Low Dose Naltrexone
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose NaltrexoneDrug
Also called LDN
4.5mg daily dose, orally, during 26 days
Transcranial Direct Current StimulationDevice
Also called tDCS
An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.
PlaceboDrug
The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.
Sham Transcranial Direct Current StimulationDevice
Also called Sham tDCS
Sham-tDCS stimulation consists of an active current during 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| LDN + tDCS | Active comparator | Low Dose Naltrexone and Transcranial Direct Current Stimulation Receives: Drug: Low-Dose Naltrexone; Device: Transcranial Direct Current Stimulation |
| LDN + Sham tDCS | Sham comparator | Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation Receives: Drug: Low-Dose Naltrexone; Device: Sham Transcranial Direct Current Stimulation |
| Placebo + tDCS | Placebo comparator | Placebo and Transcranial Direct Current Stimulation Receives: Device: Transcranial Direct Current Stimulation; Drug: Placebo |
| Placebo + Sham tDCS | Other | Placebo and Sham Transcranial Direct Current Stimulation Receives: Drug: Placebo; Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in VAS
Visual Analogue Scale (VAS) that goes from 0 cm (without pain) to 10cm (worst pain).
Measured: Change between baseline and after association (26 days from baseline)
Secondary outcomes (7)
Depressive symptoms
Beck Depression Inventory (BDI-II) that goes from 0 (without depressive symptoms) to 63 (worst depressive symptoms)
Measured: Change between baseline and after association (26 days from baseline)
Anxiety levels
State-Trait Anxiety Inventory (STAI) divided into state anxiety (from 0 to 52, the higher the worse) and trait anxiety (from 0 to 48, the higher the worse)
Measured: Change between baseline and after association (26 days from baseline)
Pain Catastrophizing Thought
Pain Catastrophizing Scale (PCS): divided into rumination (from 0 to 16, the higher the worse), magnification (from 0 to 12, the higher the worse) and hopelessness (from 0 to 24, the higher the worse). Total goes from 0 to 52, the higher the worse
Measured: Change between baseline and after association (26 days from baseline)
Profile of Chronic Pain
Profile of Chronic Pain Scale (PCP:S): divided into Frequency and Intensity of Pain (from 0 to 30, the higher the worse), Pain Effect in Activities (from 0 to 36, the higher the worse) and Pain Effect in Emotions (from 0 to 25, the higher the worse)
Measured: Change between baseline and after association (26 days from baseline)
Pain Pressure Threshold
Pain Pressure Threshold (PPT) measured using an electronic algometer applied in the right forearm; and patients need to report the first pain sensation (minimum pain) and maximum pain. Threshold goes from 0 to the maximum value the patient can hold, the higher the value, better is the result
Measured: Change between baseline and after association (26 days from baseline)
Conditioned Pain Modulation
Conditioned Pain Modulation (CPM) with an algometer (PPT task), the patient informed when felt a pain equal to 6 in the VAS. This pain level was applied in the right forearm for 30 seconds, while the left forearm (non-dominant hand) was submerged in water from 0˚C to 1.5˚C; after 30s, patients reported their pain in each of the arms. CPM = left forearm VAS - 6. (from -4 to 6, the value must be as closest to -4 as possible, meaning the higher the worse)
Measured: Change between baseline and after association (26 days from baseline)
Serum BDNF
Blood sample collected and centrifuged, the supernatant aliquoted for BDNF analysis using ELISA technique, according to manufacturer's instructions (values start in 0, patients with fibromyalgia usually have higher levels of serum BDNF, therefore the higher the worse)
Measured: Change between baseline and after association (26 days from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blinded, parallel, controlled with placebo and sham stimulation, clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Responsible party
- Principal investigator, Andressa de Souza, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502251
- Sponsor's protocol ID
- 70005317.5.0000.5307
- Status last verified
- Aug 2020
- First submitted
- 25 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
PubMed 24737367van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.
PubMed 23794640Chapman CR, Nakamura Y. A passion of the soul: an introduction to pain for consciousness researchers. Conscious Cogn. 1999 Dec;8(4):391-422. doi: 10.1006/ccog.1999.0411.
PubMed 10600241Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007 Jun;36(6):339-56. doi: 10.1016/j.semarthrit.2006.12.009. Epub 2007 Mar 13.
PubMed 17350675Burgmer M, Pogatzki-Zahn E, Gaubitz M, Wessoleck E, Heuft G, Pfleiderer B. Altered brain activity during pain processing in fibromyalgia. Neuroimage. 2009 Jan 15;44(2):502-8. doi: 10.1016/j.neuroimage.2008.09.008. Epub 2008 Sep 24.
PubMed 18848998Harris RE, Gracely RH, McLean SA, Williams DA, Giesecke T, Petzke F, Sen A, Clauw DJ. Comparison of clinical and evoked pain measures in fibromyalgia. J Pain. 2006 Jul;7(7):521-7. doi: 10.1016/j.jpain.2006.01.455.
PubMed 16814691Sluka KA, Clauw DJ. Neurobiology of fibromyalgia and chronic widespread pain. Neuroscience. 2016 Dec 3;338:114-129. doi: 10.1016/j.neuroscience.2016.06.006. Epub 2016 Jun 9.
PubMed 27291641Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.
PubMed 18191990Lobo CP, Pfalzgraf AR, Giannetti V, Kanyongo G. Impact of invalidation and trust in physicians on health outcomes in fibromyalgia patients. Prim Care Companion CNS Disord. 2014 Oct 9;16(5):10.4088/PCC.14m01664. doi: 10.4088/PCC.14m01664. eCollection 2014.
PubMed 25667809Fitzcharles MA, Ste-Marie PA, Mailis A, Shir Y. Adjudication of fibromyalgia syndrome: challenges in the medicolegal arena. Pain Res Manag. 2014 Nov-Dec;19(6):287-92. doi: 10.1155/2014/742830.
PubMed 25479148Wolfe 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 2306288Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
PubMed 27916278Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.
PubMed 23359310Parker CE, Nguyen TM, Segal D, MacDonald JK, Chande N. Low dose naltrexone for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2018 Apr 1;4(4):CD010410. doi: 10.1002/14651858.CD010410.pub3.
PubMed 29607497
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia: Randomized Clinical Trial, Blind, Controlled With Placebo
- ClinicalTrials.gov ID
- NCT04502251
- Acronym / sponsor ID
- 70005317.5.0000.5307
- Conditions
- Fibromyalgia
- Keywords
- tDCS, LDN, Transcranial Direct Current Stimulation, Low Dose Naltrexone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- 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 is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current Stimulation (tDCS), have been shown effective for pain management. This study aims to evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in fibromyalgia patients. This is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. Patients will be allocated into 4 groups: tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic Factor (BDNF) serum levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized, double-blinded, parallel, controlled with placebo and sham stimulation, clinical trial.
| Arm | Type | Receives |
|---|---|---|
| LDN + tDCS | Active comparator | Drug: Low-Dose Naltrexone, Device: Transcranial Direct Current StimulationLow Dose Naltrexone and Transcranial Direct Current Stimulation |
| LDN + Sham tDCS | Sham comparator | Drug: Low-Dose Naltrexone, Device: Sham Transcranial Direct Current StimulationLow Dose Naltrexone and Sham Transcranial Direct Current Stimulation |
| Placebo + tDCS | Placebo comparator | Device: Transcranial Direct Current Stimulation, Drug: PlaceboPlacebo and Transcranial Direct Current Stimulation |
| Placebo + Sham tDCS | Other | Drug: Placebo, Device: Sham Transcranial Direct Current StimulationPlacebo and Sham Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- signed the consent form
- women from 18 to 65 years
- confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria
- read and write
- pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months
Key exclusion criteria (11 listed)
- in use of opioid drugs;
- pregnancy or not using anticontraceptive
- history of alcohol or drug abuse in the last 6 months
- history of neurological pathologies
- history of arrhythmia
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 |
|---|---|---|
| Low-Dose NaltrexoneAlso: LDN4.5mg daily dose, orally, during 26 days | Drug | LDN + Sham tDCS, LDN + tDCS |
| Transcranial Direct Current StimulationAlso: tDCSAn anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes. | Device | LDN + tDCS, Placebo + tDCS |
| PlaceboThe capsule presented the same format, size and color as LDN capsules, however the excipient used was starch. | Drug | Placebo + Sham tDCS, Placebo + tDCS |
| Sham Transcranial Direct Current StimulationAlso: Sham tDCSSham-tDCS stimulation consists of an active current during 30 seconds | Device | LDN + Sham tDCS, Placebo + Sham tDCS |
Primary outcome
Pain in VAS
Time frame: Change between baseline and after association (26 days from baseline)
Visual Analogue Scale (VAS) that goes from 0 cm (without pain) to 10cm (worst pain).
7 secondary outcomes
Depressive symptoms
Time frame: Change between baseline and after association (26 days from baseline)
Anxiety levels
Time frame: Change between baseline and after association (26 days from baseline)
Pain Catastrophizing Thought
Time frame: Change between baseline and after association (26 days from baseline)
Profile of Chronic Pain
Time frame: Change between baseline and after association (26 days from baseline)
Pain Pressure Threshold
Time frame: Change between baseline and after association (26 days from baseline)
Conditioned Pain Modulation
Time frame: Change between baseline and after association (26 days from baseline)
Serum BDNF
Time frame: Change between baseline and after association (26 days from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 24737367Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.
- Background: PubMed 23794640van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.
- Background: PubMed 10600241Chapman CR, Nakamura Y. A passion of the soul: an introduction to pain for consciousness researchers. Conscious Cogn. 1999 Dec;8(4):391-422. doi: 10.1006/ccog.1999.0411.
- Background: PubMed 17350675Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007 Jun;36(6):339-56. doi: 10.1016/j.semarthrit.2006.12.009. Epub 2007 Mar 13.
- Background: PubMed 18848998Burgmer M, Pogatzki-Zahn E, Gaubitz M, Wessoleck E, Heuft G, Pfleiderer B. Altered brain activity during pain processing in fibromyalgia. Neuroimage. 2009 Jan 15;44(2):502-8. doi: 10.1016/j.neuroimage.2008.09.008. Epub 2008 Sep 24.
- Background: PubMed 16814691Harris RE, Gracely RH, McLean SA, Williams DA, Giesecke T, Petzke F, Sen A, Clauw DJ. Comparison of clinical and evoked pain measures in fibromyalgia. J Pain. 2006 Jul;7(7):521-7. doi: 10.1016/j.jpain.2006.01.455.
- Background: PubMed 27291641Sluka KA, Clauw DJ. Neurobiology of fibromyalgia and chronic widespread pain. Neuroscience. 2016 Dec 3;338:114-129. doi: 10.1016/j.neuroscience.2016.06.006. Epub 2016 Jun 9.
- Background: PubMed 18191990Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.
- Background: PubMed 25667809Lobo CP, Pfalzgraf AR, Giannetti V, Kanyongo G. Impact of invalidation and trust in physicians on health outcomes in fibromyalgia patients. Prim Care Companion CNS Disord. 2014 Oct 9;16(5):10.4088/PCC.14m01664. doi: 10.4088/PCC.14m01664. eCollection 2014.
- Background: PubMed 25479148Fitzcharles MA, Ste-Marie PA, Mailis A, Shir Y. Adjudication of fibromyalgia syndrome: challenges in the medicolegal arena. Pain Res Manag. 2014 Nov-Dec;19(6):287-92. doi: 10.1155/2014/742830.
- 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 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-Dose Naltrexone and Transcranial Direct Current Stimulation in people with Fibromyalgia, run by Centro Universitario La Salle at 1 site in Brazil.
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: finished, as of the sponsor's last update on 6 Aug 2020. 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain in VAS (time frame: Change between baseline and after association (26 days from baseline)). 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 NCT04502251, which also lists 35 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 6 Aug 2020; AzTrials last refreshed its copy on 26 Oct 2026.