FibromyalgiaNCT03911882
Efficacy and Tolerability of CELERGEN in Fibromyalgia
An observational study of Fibromyalgia, run by Celergan SA at 1 site in Spain.
Trial summary
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of marine sperm extract, hydrolyzed collagen, CoQ10, lutein and selenium. This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Celergen Administration
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 29 Apr 2016to 30 Aug 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Caucasian 18-60 years
Who may be able to join
- Adult patients with an established diagnosis of fibromyalgia according to the diagnostic criteria of the American College of Rheumatology of the year 2010.
- Patients who signed the informed consent to participate in the study
Who cannot join
- Patients suffering from any psychiatric disorder specified on Axis I DSM-IV- R other than major depression.
- Patients with a history or currently part of substance abuse.
- Patients who are pregnant or breastfeeding.
- Patients taking other dietary supplements with or without antioxidant character, or who are being treated with ozone therapy systemically.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of marine sperm extract, hydrolyzed collagen, CoQ10, lutein and selenium. This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. The study duration was 90 days and patients were evaluated by the: FIQ-R Fibromyalgia Impact Questionnaire Revised, Questionnaire of Health SF-12, Scale Clinical Global Impression Improvement assessed by the patient (PGI), and the Brief Pain Inventory (BPI). Blood samples were obtained at weeks 0 and 12 order for serum levels of Substance P and Tumor Necrosis Factor to measured blindly. Statistical analysis will be performed by analysis of variance for paired data.
Read the detailed description
Fibromyalgia Syndrome (FMS) is a disease characterized by chronic widespread pain, along with muscle stiffness, sleep disorders, chronic fatigue, anxiety, depression, or neurocognitive deficiencies and autoimmune dysfunction. FMS prevalence is about 2% of the general population. Recently, a European study found a prevalence of 4.7% in all five countries surveyed, including Spain. The etiology of FMS is still unknown, but recent evidence supports the involvement of neuro-inflammation.
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of a proprietory mixture of herring and mackerel milt semen and sperm-filled reproductive gland of male fish provided by Celergen Ltd, Luxemburg), hydrolyzed collagen, CoQ10, lutein and selenium.
This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. The study duration was 90 days and patients were evaluated by the following:
INSTRUMENTS OF ASSESSMENT:
- Fibromyalgia Impact Questionnaire Revised (FIQR): The most commonly used scale to assess the severity and impact of fibromialgia.
- Brief Pain Inventory (BPI): Evaluates both pain intensity and interference with daily activities. The validated Spanish version will be used.
- Questionnaire of Health SF-12: This questionnaire, shortened version of the SF-36 version, has shown strong correlation with the latter both in relation to the physical and mental summary, presenting the advantage of its reduced complexity.
- Scale Clinical Global Impression Improvement assessed by the patient (PGI): A Likert scale of 7 points ranging from 1 (much better) to 7 (very much worse). It is used in most studies and clinical trials to assess the patients perception of the evolution of the disease in relation to the prescribed treatment.
COURSE OF STUDY:
The total duration of the study will be 12 weeks. Visit 1 (Week -0). - A general medical history, in which the possible diseases suffered by the patient and the medications they are taking for treatment is recorded, which should not be changed during the study. Data relating to previous or ongoing treatments (pharmacological or not) for FMS will also be collected. The inclusion and exclusion criteria will be checked, informed consent will be obtained. and blood will be drawn and stored at -80o C until the end of the study for biochemical analysis and comparison with blood drawn at the end of the study.
Visit 2 (baseline). - FIQR and the SF-12 and BPI questionnaires will be completed.
Celergen® treatment, to be administered as an adjunct to medication the patient is taking. A Celergen® capsule will be prescribed after breakfast, unmixed with taking other supplement or medication.
Visit 3 (Week 1). The FIQ, the BIS, the SF-12 and PGI questionnaires will be completed.
Visit 4 (Week 4). - Supplement tolerability will be assessed by recording the occurrence of adverse effects. The FIQ, the BIS, the SF-12 and PGI questionnaires will be completed.
Visit 5 (Week 8). - Supplement tolerability will be assessed by recording the occurrence of any adverse effects. The FIQ, the BIS, the SF-12 and PGI questionnaires will be completed.
Visit 6 (Week 12). - The FIQ, the BIS, the PGI, the SF-12 and PGI questionnaires will be completed. The end of the treatment will be recorded. Potential adverse reactions will be also be recorded. Final blood samples will be drawn for biochemical analysis.
STATISTICAL ANALYSIS:
Both the primary variable (the change in the initial and final mean scores of FIQ) and other quantitative variables (differences in mean scores on the BIS and SF-12) will be evaluated by analysis of variance for paired data.
Adverse reactions and PGI will be analyzed using descriptive statistics.
- Conditions
- Fibromyalgia
- Being tested
- Celergen Administration
- Keywords
- Fibromyalgia, Cytokines, TNF, Substance P, Spermine, Pain, Fatigue
- Medical subject headings
- Fibromyalgia, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celergen AdministrationDietary supplement
The food supplement Celergen was administered on a daily basis for a total of 3 months (90 days) to participating fibromyalgia patients
| Study group | Role | What they receive |
|---|---|---|
| Celergen Administration | The food supplement Celergen was administered to fibromyalgia patients following a protocol of a daily intake for the period of a total of 3 months (90 days) Receives: Dietary Supplement: Celergen Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire Revised
Scale measuring overall fibromyalgia symptoms (0-100) For each symptom-based item (Questions 14 - 20) the raw score ranges from 0 to 10. If the patient marks between 2 hash marks the item is given a score that includes 0.5. Do Job: (Question 14) Raw score is final score. Pain: (Question 15) Raw score is final score. Fatigue: (Question 16) Raw score is final score. Rested: (Question 17) Raw score is final score. Stiffness: (Question 18) Raw score is final score. Anxiety: (Question 19) Raw score is final score. Depression: (Question 20) Raw score is final score. In each instance, the final score is the sum of the scores for the Physical Impairment, Feel Good, Pain, Fatigue, Rested, Stiffness, Anxiety, and Depression scales (does not include 2 work items.)
Measured: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Brief Pain Inventory
Scale measuring pain frequency and intensity (0-10) Brief Pain Inventory (Short Form) 2. On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most.
Yes No 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 4. Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours. 6. Please rate your pain by marking the box beside the number that tells how much pain you have right now.
0 1 2 3 4 5 6 7
Measured: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Questionnaire of Health SF-12
Scale measuring quality of life (0-100) Choose one option for each questionnaire item.
- In general, would you say your health is:
- - Excellent
- - Very good
- - Good
- - Fair
- - Poor
- For how long (if at all) has your health limited you in each of the following activities?
Limited for more than 3 months Limited for 3 months or less Not limited at all
- The kinds or amounts of vigorous activities you can do, like lifting heavy objects, running or participating in strenuous sports 1 2 3
- The kinds or amounts of moderate activities you can do, like moving a table, carrying groceries, or bowling 1 2 3
- Walking uphill or climbing a few flights of stairs 1 2 3
- Bending, lifting, or stooping 1 2 3
- Walking one block 1 2 3
- Eating, dressing, bathing, or using the toilet
- 2 3 3. How much bodily pain have you had during the past 4 weeks: <!-- -->
- - None
- - Very mild
- - Mild
- - Moderate
Measured: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Clinical Global Impression Improvement assessed by the patient (PGI)
Scale measuring overall improvement (0-7) Severity scale The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are:[1]
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients Improvement scale The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:[1]
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Secondary outcomes (2)
Serum TNF level
ELISA measurement
Measured: Compare levels at T=1 week with levels at T=12 week
Serum Substance P level
ELISA measurement
Measured: Compare levels at T=1 week 1 with levels at T=12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start29 Apr 2016
- Primary completion29 Jul 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celergan SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Freitag, Study director, Clinica DFK, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911882
- Sponsor's protocol ID
- CELERGEN6007
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Catanzaro R, Celep G, Zerbinati N, Papacharalambous M, Nagpal R, Marotta F, Rastmanesh R, Milazzo M, Lorenzetti A, Bertuccelli G, Sollano J. In vitro protective effect of Celergen, a bioactive marine compound, on interleukin-6-related invasiveness of pancreatic cancer. Acta Biomed. 2014 May 9;85(1):44-51.
PubMed 24897969Catanzaro R, Zerbinati N, Solimene U, Celep G, Marotta F, Kushugulova A, Milazzo M, Tomella C, Bertuccelli G, Zhumadilov Z. Effect of Celergen, a marine derivative, on in vitro hepatocarcinogenesis. Drug Discov Ther. 2013 Oct;7(5):196-200.
PubMed 24270384Tsilioni I, Pipis H, Freitag MSC, Izquierdo MDC, Freitag K, Theoharides TC. Effects of an Extract of Salmon Milt on Symptoms and Serum TNF and Substance P in Patients With Fibromyalgia Syndrome. Clin Ther. 2019 Aug;41(8):1564-1574.e2. doi: 10.1016/j.clinthera.2019.05.019. Epub 2019 Jul 11.
PubMed 31303280
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03911882
- Acronym / sponsor ID
- CELERGEN6007
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cytokines, TNF, Substance P, Spermine, Pain, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Celergan SAIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 11 Apr 2019 (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.
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of marine sperm extract, hydrolyzed collagen, CoQ10, lutein and selenium. This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. The study duration was 90 days and patients were evaluated by the: FIQ-R Fibromyalgia Impact Questionnaire Revised, Questionnaire of Health SF-12, Scale Clinical Global Impression Improvement assessed by the patient (PGI), and the Brief Pain Inventory (BPI). Blood samples were obtained at weeks 0 and 12 order for serum levels of Substance P and Tumor Necrosis Factor to measured blindly. Statistical analysis will be performed by analysis of variance for paired data.
Detailed description
Fibromyalgia Syndrome (FMS) is a disease characterized by chronic widespread pain, along with muscle stiffness, sleep disorders, chronic fatigue, anxiety, depression, or neurocognitive deficiencies and autoimmune dysfunction. FMS prevalence is about 2% of the general population. Recently, a European study found a prevalence of 4.7% in all five countries surveyed, including Spain. The etiology of FMS is still unknown, but recent evidence supports the involvement of neuro-inflammation.
Celergén® is a dietary supplement with anti-inflammatory and antioxidant properties composed of a proprietory mixture of herring and mackerel milt semen and sperm-filled reproductive gland of male fish provided by Celergen Ltd, Luxemburg), hydrolyzed collagen, CoQ10, lutein and selenium.
This is an open-label, prospective, study to evaluate the efficacy and tolerability of Celergen in 90 patients with Fibromyalgia. The study duration was 90 days and patients were evaluated by the following:
INSTRUMENTS OF ASSESSMENT:
- Fibromyalgia Impact Questionnaire Revised (FIQR): The most commonly used scale to assess the severity and impact of fibromialgia.
- Brief Pain Inventory (BPI): Evaluates both pain intensity and interference with daily activities. The validated Spanish version will be used.
- Questionnaire of Health SF-12: This questionnaire, shortened version of the SF-36 version, has shown strong correlation with the latter both in relation to the physical and mental summary, presenting the advantage of its reduced complexity.
- Scale Clinical Global Impression Improvement assessed by the patient (PGI): A Likert scale of 7 points ranging from 1 (much better) to 7 (very much worse). It is used in most studies and clinical trials to assess the patients perception of the evolution of the disease in relation to the prescribed treatment.
COURSE OF STUDY:
The total duration of the study will be 12 weeks. Visit 1 (Week -0). - A general medical history, in which the possible diseases suffered by the patient and the medications they are taking for treatment is recorded, which should not be changed during the study. Data relating to previous or ongoing treatments (pharmacological or not) for FMS will also be collected. The inclusion and exclusion criteria will be checked, informed consent will be obtained. and blood will be drawn and stored at -80o C until the end of the study for biochemical analysis and comparison with blood drawn at the end of the study.
Visit 2 (baseline). - FIQR and the SF-12 and BPI questionnaires will be completed.
Celergen® treatment, to be administered as an adjunct to medication the patient is taking. A Celergen® capsule will be prescribed after breakfast, unmixed with taking other supplement or medication.
Visit 3 (Week 1). The FIQ, the BIS, the SF-12 and PGI questionnaires will be completed.
Visit 4 (Week 4). - Supplement tolerability will be assessed by recording the occurrence of adverse effects. The FIQ, the BIS, the SF-12 and PGI questionnaires will be completed.
Visit 5 (Week 8). - Supplement tolerability will be assessed by recording the occurrence of any adverse effects. The FIQ, the BIS, the SF-12 and PGI questionnaires will be completed.
Visit 6 (Week 12). - The FIQ, the BIS, the PGI, the SF-12 and PGI questionnaires will be completed. The end of the treatment will be recorded. Potential adverse reactions will be also be recorded. Final blood samples will be drawn for biochemical analysis.
STATISTICAL ANALYSIS:
Both the primary variable (the change in the initial and final mean scores of FIQ) and other quantitative variables (differences in mean scores on the BIS and SF-12) will be evaluated by analysis of variance for paired data.
Adverse reactions and PGI will be analyzed using descriptive statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celergen Administration | – | Dietary Supplement: Celergen AdministrationThe food supplement Celergen was administered to fibromyalgia patients following a protocol of a daily intake for the period of a total of 3 months (90 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Caucasian 18-60 years
Key inclusion criteria (2 listed)
- Adult patients with an established diagnosis of fibromyalgia according to the diagnostic criteria of the American College of Rheumatology of the year 2010.
- Patients who signed the informed consent to participate in the study
Key exclusion criteria (4 listed)
- Patients suffering from any psychiatric disorder specified on Axis I DSM-IV- R other than major depression.
- Patients with a history or currently part of substance abuse.
- Patients who are pregnant or breastfeeding.
- Patients taking other dietary supplements with or without antioxidant character, or who are being treated with ozone therapy systemically.
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 |
|---|---|---|
| Celergen AdministrationThe food supplement Celergen was administered on a daily basis for a total of 3 months (90 days) to participating fibromyalgia patients | Dietary supplement | Celergen Administration |
Primary outcome
Fibromyalgia Impact Questionnaire Revised
Time frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Scale measuring overall fibromyalgia symptoms (0-100) For each symptom-based item (Questions 14 - 20) the raw score ranges from 0 to 10. If the patient marks between 2 hash marks the item is given a score that includes 0.5. Do Job: (Question 14) Raw score is final score. Pain: (Question 15) Raw score is final score. Fatigue: (Question 16) Raw score is final score. Rested: (Question 17) Raw score is final score. Stiffness: (Question 18) Raw score is final score. Anxiety: (Question 19) Raw score is final score. Depression: (Question 20) Raw score is final score. In each instance, the final score is the sum of the scores for the Physical Impairment, Feel Good, Pain, Fatigue, Rested, Stiffness, Anxiety, and Depression scales (does not include 2 work items.)
Brief Pain Inventory
Time frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Scale measuring pain frequency and intensity (0-10) Brief Pain Inventory (Short Form) 2. On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most. Yes No 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 4. Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours. 6. Please rate your pain by marking the box beside the number that tells how much pain you have right now. 0 1 2 3 4 5 6 7
Questionnaire of Health SF-12
Time frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Scale measuring quality of life (0-100) Choose one option for each questionnaire item. 1. In general, would you say your health is: 1. - Excellent 2. - Very good 3. - Good 4. - Fair 5. - Poor 2. For how long (if at all) has your health limited you in each of the following activities? Limited for more than 3 months Limited for 3 months or less Not limited at all 1. The kinds or amounts of vigorous activities you can do, like lifting heavy objects, running or participating in strenuous sports 1 2 3 2. The kinds or amounts of moderate activities you can do, like moving a table, carrying groceries, or bowling 1 2 3 3. Walking uphill or climbing a few flights of stairs 1 2 3 4. Bending, lifting, or stooping 1 2 3 5. Walking one block 1 2 3 6. Eating, dressing, bathing, or using the toilet 1. 2 3 3. How much bodily pain have you had during the past 4 weeks: <!-- --> 1. - None 2. - Very mild 3. - Mild 4. - Moderate
Clinical Global Impression Improvement assessed by the patient (PGI)
Time frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Scale measuring overall improvement (0-7) Severity scale The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are:[1] Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients Improvement scale The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:[1] Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
2 secondary outcomes
Serum TNF level
Time frame: Compare levels at T=1 week with levels at T=12 week
Serum Substance P level
Time frame: Compare levels at T=1 week 1 with levels at T=12 week
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 16 Apr 2019.
- Results publication: PubMed 24897969Catanzaro R, Celep G, Zerbinati N, Papacharalambous M, Nagpal R, Marotta F, Rastmanesh R, Milazzo M, Lorenzetti A, Bertuccelli G, Sollano J. In vitro protective effect of Celergen, a bioactive marine compound, on interleukin-6-related invasiveness of pancreatic cancer. Acta Biomed. 2014 May 9;85(1):44-51.
- Results publication: PubMed 24270384Catanzaro R, Zerbinati N, Solimene U, Celep G, Marotta F, Kushugulova A, Milazzo M, Tomella C, Bertuccelli G, Zhumadilov Z. Effect of Celergen, a marine derivative, on in vitro hepatocarcinogenesis. Drug Discov Ther. 2013 Oct;7(5):196-200.
- Derived from this study: PubMed 31303280Tsilioni I, Pipis H, Freitag MSC, Izquierdo MDC, Freitag K, Theoharides TC. Effects of an Extract of Salmon Milt on Symptoms and Serum TNF and Substance P in Patients With Fibromyalgia Syndrome. Clin Ther. 2019 Aug;41(8):1564-1574.e2. doi: 10.1016/j.clinthera.2019.05.019. Epub 2019 Jul 11.
- Individual participant dataSharing planned: No
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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.
Karin Freitag study director
Clinica DFK, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Celergan SA 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 2 inclusion and 4 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 16 Apr 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fibromyalgia Impact Questionnaire Revised (time frame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)). The study lists 4 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 NCT03911882, which also lists 3 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 16 Apr 2019.