Clinical trial NCT03911882: Efficacy and Tolerability of CELERGEN in Fibromyalgia
Official title: A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Cytokines
TNF
Substance P
Spermine
Pain
Fatigue
Lead sponsor: Celergan SA
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Caucasian 18-60 years

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire Revised
timeFrame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
measure: Brief Pain Inventory
timeFrame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
measure: Questionnaire of Health SF-12
timeFrame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
measure: Clinical Global Impression Improvement assessed by the patient (PGI)
timeFrame: Compare values at T=week 1 (before treatment) with those at T=week 12 (end)
Secondary outcomes:
measure: Serum TNF level
timeFrame: Compare levels at T=1 week with levels at T=12 week
measure: Serum Substance P level
timeFrame: Compare levels at T=1 week 1 with levels at T=12 week
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinica DFK
Study officials:
affiliation: Clinica DFK, Madrid, Spain
name: Karin Freitag
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Catanzaro 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.
citation: Tsilioni 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.