FibromyalgiaPhase 2/3NCT02041455
Immune-Pineal Axis Function in Fibromyalgia
A Phase 2/3 study testing Melatonin and Amitriptylin in people with Fibromyalgia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome . Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Melatonin and Amitriptylin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Mar 2014
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18-65 years old
- Fibromyalgia according to the criteria of the American College of Rheumatology (Wolfe 2010)
- Sign the informed consent
- Patients can take medication for chronic pain ( antidepressants , antiepileptics, for example), since there are at least two months
Who cannot join
- patients who did not understand the Portuguese
- diagnosis of malignancies, severe psychiatric disorders , sleep disorders not related to fibromyalgia (apnea , sleepwalking , restless leg syndrome), Alzheimer's disease or any disease (rheumatologic, neurological, etc.) that can modify the evaluations or outcomes
- alcohol abuse or drug addiction
- patients who are performing acupuncture
- BMI greater than 35 ( BMI = body mass index) .
- Patients with history of allergy to amitriptyline or/and melatonin or any other contraindication for the use of these drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 900035-903
Simone de Azevedo Zanette, MD, 555133598430
Wolnei Caumo, PhD
About this study
Official title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .
Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .
Read more
The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.
The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.
- Conditions
- Fibromyalgia
- Being tested
- Melatonin and Placebo, Amitriptyline and Placebo, Melatonin and Amitriptylin
- Keywords
- Fibromyalgia, Melatonin, Amitriptylin, Imune-pineal axis
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin and PlaceboDrug
Amitriptyline and PlaceboDrug
Melatonin and AmitriptylinDrug
| Study group | Role | What they receive |
|---|---|---|
| Melatonin and Placebo | Experimental | Melatonin 10mg and placebo, once in the evening, for 6 weeks. Receives: Drug: Melatonin and Placebo |
| Amitriptyline and placebo | Experimental | Amitriptyline 25mg and placebo, once in the evening, for 6 weeks. Receives: Drug: Amitriptyline and Placebo |
| Melatonin and Amitriptylin | Active comparator | Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks. Receives: Drug: Melatonin and Amitriptylin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Measured: Baseline, week 6
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
Pain Pressure Threshold by Fischer algometer on the tender points.
Measured: Baseline, week 6
Change from Baseline Brain-derived neurotrophic factor at week 6
Measured: Baseline, week 6
Secondary outcomes (2)
Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6
Measured: Baseline, week 6
Change from Baseline of the Pain Catastrophizing Scale at week 6
Catastrophic thinking related to pain
Measured: Baseline; week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJun 2010
- Primary completionJan 2014
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolnei d Caumo, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041455
- Sponsor's protocol ID
- 09-261
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Zanette SA, Vercelino R, Laste G, Rozisky JR, Schwertner A, Machado CB, Xavier F, de Souza IC, Deitos A, Torres IL, Caumo W. Melatonin analgesia is associated with improvement of the descending endogenous pain-modulating system in fibromyalgia: a phase II, randomized, double-dummy, controlled trial. BMC Pharmacol Toxicol. 2014 Jul 23;15:40. doi: 10.1186/2050-6511-15-40.
PubMed 25052847
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
- ClinicalTrials.gov ID
- NCT02041455
- Acronym / sponsor ID
- 09-261
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Melatonin, Amitriptylin, Imune-pineal axis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 22 Jan 2014 (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 is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .
Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .
The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.
The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin and Placebo | Experimental | Drug: Melatonin and PlaceboMelatonin 10mg and placebo, once in the evening, for 6 weeks. |
| Amitriptyline and placebo | Experimental | Drug: Amitriptyline and PlaceboAmitriptyline 25mg and placebo, once in the evening, for 6 weeks. |
| Melatonin and Amitriptylin | Active comparator | Drug: Melatonin and AmitriptylinMelatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 18-65 years old
- Fibromyalgia according to the criteria of the American College of Rheumatology (Wolfe 2010)
- Sign the informed consent
- Patients can take medication for chronic pain ( antidepressants , antiepileptics, for example), since there are at least two months
Key exclusion criteria (6 listed)
- patients who did not understand the Portuguese
- diagnosis of malignancies, severe psychiatric disorders , sleep disorders not related to fibromyalgia (apnea , sleepwalking , restless leg syndrome), Alzheimer's disease or any disease (rheumatologic, neurological, etc.) that can modify the evaluations or outcomes
- alcohol abuse or drug addiction
- patients who are performing acupuncture
- BMI greater than 35 ( BMI = body mass index) .
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 |
|---|---|---|
| Melatonin and Placebo | Drug | Melatonin and Placebo |
| Amitriptyline and Placebo | Drug | Amitriptyline and placebo |
| Melatonin and Amitriptylin | Drug | Melatonin and Amitriptylin |
Primary outcome
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Time frame: Baseline, week 6
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
Time frame: Baseline, week 6
Pain Pressure Threshold by Fischer algometer on the tender points.
Change from Baseline Brain-derived neurotrophic factor at week 6
Time frame: Baseline, week 6
2 secondary outcomes
Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6
Time frame: Baseline, week 6
Change from Baseline of the Pain Catastrophizing Scale at week 6
Time frame: Baseline; week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Derived from this study: PubMed 25052847de Zanette SA, Vercelino R, Laste G, Rozisky JR, Schwertner A, Machado CB, Xavier F, de Souza IC, Deitos A, Torres IL, Caumo W. Melatonin analgesia is associated with improvement of the descending endogenous pain-modulating system in fibromyalgia: a phase II, randomized, double-dummy, controlled trial. BMC Pharmacol Toxicol. 2014 Jul 23;15:40. doi: 10.1186/2050-6511-15-40.
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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.
Wolnei d Caumo, PhD study director
Hospital de Clinicas de Porto Alegre
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 Melatonin and Amitriptylin in people with Fibromyalgia, run by Hospital de Clinicas de Porto Alegre 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 4 inclusion and 6 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 22 Jan 2014. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolnei Caumo, PhD (555133598083, caumo@cpovo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (time frame: Baseline, week 6). The study lists 3 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 NCT02041455, which also lists 1 linked publication.
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 22 Jan 2014.