Spinocerebellar Ataxia Type 3NCT04419974
Astrocytic Markers and the Pre-ataxic Period of SCA3/MJD - BIGPRO Study Astrocytes
An observational study of Spinocerebellar Ataxia Type 3 and Machado-Joseph Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The study will consist of a prospective observation of subjects in a natural history design. The investigators will monitor changes of clinical scales, quality of life, messenger ribonucleic acid (mRNA) of candidate genes (CCL11, TNFSF14, FCGR3B, CLC, and SLA) (and their peptide products, when possible), and eotaxin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Ataxia Type 3, Machado-Joseph Disease, SCA3
- What is being tested?
- Molecular Diagnosis, Clinical Scales - Baseline and Blood Draw - Baseline
- How many people
- 95 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Mar 2017to Aug 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with molecular diagnosis of SCA3/MJD will be recruited from the Medical Genetics Service database of Hospital de Clínicas de Porto Alegre, Brazil, by telephone calls or by invitation in the outpatient clinic. First degree relatives of these subjects at 50% risk of carrying the mutation will also be invited to participate.
Who may be able to join
- Individuals with molecular diagnosis of SCA3/MJD
- Individuals at 50% risk of inheriting SCA3/MJD mutation without any clinical manifestation
Who cannot join
- Refusal to sign informed consent
- Other diagnosed neurological conditions;
- Diabetes Mellitus;
- Chronic allergy (asthma, eczema, urticaria)
- Eosinophilia on baseline
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Biomarkers and Genetic Modifiers in a Study of Pre-ataxic and Ataxic SCA3/MJD Carriers (BIGPRO Study) - Astrocytes
The study will consist of a prospective observation of subjects in a natural history design. The investigators will monitor changes of clinical scales, quality of life, messenger ribonucleic acid (mRNA) of candidate genes (CCL11, TNFSF14, FCGR3B, CLC, and SLA) (and their peptide products, when possible), and eotaxin and S100B serum levels, in order to determine which of them is (are) the most sensitive. Participants will be stratified in three groups: ataxic carriers, pre-ataxic carriers and non-carriers (controls).
Read the detailed description
Spinocerebellar ataxia type 3, or Machado-Joseph disease (SCA3/MJD), is an autosomal dominant neurodegenerative disorder caused by a CAG expansion at ATXN3. The gene product is a 42kDa protein called ataxin-3, widely expressed in neurons and peripheral tissues. Physiological roles of ataxin-3 include, at least, ubiquitination and regulation of misfolded proteins, cytoskeletal organization and focal adhesions development, and transcriptional regulation, most often as a transcriptional corepressor. One purpose of the present study is to detect a possible association between altered transcription patterns of candidate genes and disease progression. On the other hand, previous evidences suggest that the disease process linked to polyQ aggregation in neuronal cell ("cell-autonomous process") might be worsened by what happens outside the neuronal cell ("non-cell-autonomous process"). Initial evidences lead to the role of astrocytes. This is a major depart from the traditional understanding of polyglutamine diseases, and comprises the main focus of the present study.
The main hypothesis of this study is that the SCA3/MJD clinical features may be in part associated to astrocytic processes. In order to test it, peripheral level of LIGHT protein (encoded by TNFSF14) and eotaxin (encoded by CCL11) - both expressed in astrocytes -, and of S100B (a myelin damage marker), will be measured. The investigators speculate if they can be biomarkers of disease progression and of pathological process, even before symptoms onset. In case this is positive, their responsiveness to change will be tested to check if it is better than those of clinical scales.
The second aim is to test if disease progression can be associated with changes in the transcriptional pattern of candidate genes FCGR3B, CLC and SLA.
"BIGPRO study - Astrocytes" intends to identify variations in these candidates and validate them as SCA3/MJD biomarkers. The study will consist of a prospective observation of subjects in a natural history design. Changes in clinical scales, quality of life, messenger ribonucleic acid (mRNA) of candidate genes (CCL11, TNFSF14, FCGR3B, CLC, and SLA) (and their peptide products, when possible), and eotaxin and S100B serum levels will be monitored in order to determine which of them is (are) the most sensitive. Participants will be stratified in three groups: ataxic carriers, pre-ataxic carriers and non-carriers (controls). For each asymptomatic carrier, the time until start of disease will be estimated according to the individual CAG expanded sequence (CAGexp) and subject's age. Clinical scales Scale for the Assessment and Rating of Ataxia (SARA), Neurological Examination Scale for SCA (NESSCA), International Co-operative Rating Scale (ICARS), Inventory of Non-ataxia Symptoms (INAS), SCA Functional Index (SCAFI), Composite Cerebellar Functional Severity Score (CCFS) and Quality of Life measurements (EQ-5D and SF-36), will be applied at baseline, at 12 months and at 24 months, in all subjects (all three groups). Eotaxin, TNFSF14, S100B and mRNAs, will be measured in the same moments. Progression rates of all these variables will be estimated through mixed-models, including, as covariates, age, group and their interactions.
- Conditions
- Spinocerebellar Ataxia Type 3, Machado-Joseph Disease, SCA3, MJD
- Being tested
- Molecular Diagnosis, Clinical Scales - Baseline, Blood Draw - Baseline, Quality of Life Assessment - Baseline, Clinical Scales - Follow-up 12 months
- Keywords
- SCA3/MJD, SCA3, MJD, natural history, cytokines, astrocytes, quality of life
- Medical subject headings
- Machado-Joseph Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular DiagnosisDiagnostic test
Double-blind molecular diagnosis for the SCA3/MJD mutation.
Clinical Scales - BaselineDiagnostic test
SARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied on baseline.
Blood Draw - BaselineDiagnostic test
Blood collection on baseline for evaluation of
- Candidate genes expression
- Serum proteins
- Lymphocytic proteins
Quality of Life Assessment - BaselineDiagnostic test
Participants fill out 2 self-reported quality of life questionnaires.
Clinical Scales - Follow-up 12 monthsDiagnostic test
SARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied 12 months after baseline for prospective evaluation.
Blood Draw - Follow-up 12 monthsDiagnostic test
Blood collection 12 months after baseline for prospective evaluation of
- Candidate genes expression
- Serum proteins
- Lymphocytic proteins
Quality of Life Assessment - Follow-up 12 monthsDiagnostic test
Participants fill out 2 self-reported quality of life questionnaires for prospective evaluation.
Clinical Scales - Follow-up 24 monthsDiagnostic test
SARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied 24 months after baseline for prospective evaluation.
Blood Draw - Follow-up 24 monthsDiagnostic test
Blood collection 24 months after baseline for prospective evaluation of
- Candidate genes expression
- Serum proteins
- Lymphocytic proteins
Quality of Life Assessment - Follow-up 24 monthsDiagnostic test
Participants fill out 2 self-reported quality of life questionnaires for prospective evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Ataxic carriers | Subjects with a CAG repeat expansion on ATXN3 and Scale for Assessment and Rating of Ataxia (SARA) of 3 points or more. Receives: Diagnostic Test: Clinical Scales - Baseline; Diagnostic Test: Blood Draw - Baseline; Diagnostic Test: Quality of Life Assessment - Baseline; Diagnostic Test: Clinical Scales - Follow-up 12 months; Diagnostic Test: Blood Draw - Follow-up 12 months; Diagnostic Test: Quality of Life Assessment - Follow-up 12 months; Diagnostic Test: Clinical Scales - Follow-up 24 months; Diagnostic Test: Blood Draw - Follow-up 24 months; Diagnostic Test: Quality of Life Assessment - Follow-up 24 months | |
| Pre-ataxic carriers | Subjects with a CAG repeat expansion on ATXN3 and Scale for Assessment and Rating of Ataxia (SARA) of less than 3 points. Receives: Diagnostic Test: Molecular Diagnosis; Diagnostic Test: Clinical Scales - Baseline; Diagnostic Test: Blood Draw - Baseline; Diagnostic Test: Quality of Life Assessment - Baseline; Diagnostic Test: Clinical Scales - Follow-up 12 months; Diagnostic Test: Blood Draw - Follow-up 12 months; Diagnostic Test: Quality of Life Assessment - Follow-up 12 months; Diagnostic Test: Clinical Scales - Follow-up 24 months; Diagnostic Test: Blood Draw - Follow-up 24 months; Diagnostic Test: Quality of Life Assessment - Follow-up 24 months | |
| Related controls | Subjects without a CAG repeat expansion on ATXN3, but with a first degree relative affected by the disease. Receives: Diagnostic Test: Molecular Diagnosis; Diagnostic Test: Clinical Scales - Baseline; Diagnostic Test: Blood Draw - Baseline; Diagnostic Test: Quality of Life Assessment - Baseline; Diagnostic Test: Clinical Scales - Follow-up 12 months; Diagnostic Test: Blood Draw - Follow-up 12 months; Diagnostic Test: Quality of Life Assessment - Follow-up 12 months; Diagnostic Test: Clinical Scales - Follow-up 24 months; Diagnostic Test: Blood Draw - Follow-up 24 months; Diagnostic Test: Quality of Life Assessment - Follow-up 24 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum concentrations of Eotaxin
pg/ml
Measured: 24 months
Change in serum concentrations of S100B
μg/l
Measured: 24 months
Change in expression of TNFSF14
Fold change (FC)
Measured: 24 months
Change in expression of CCL11
Fold change (FC)
Measured: 24 months
Change in EQ-5D-3L (EuroQoL 5 Domains evaluated in 3 levels)
Quality of life scale evaluating 5 domains and a visual analog scale. Domain scores increase with worsening in quality of life. In the visual analog scale, worse scores mean decrease in quality of life.
Measured: 24 months
Change in SF-36 (Short-form 36)
Quality of life scale evaluating 8 domains through 36 questions. Domain scores decrease with worsening in quality of life.
Measured: 24 months
Secondary outcomes (3)
Change in expression of FCGR3B
Fold change (FC)
Measured: 24 months
Change in expression of CLC
Fold change (FC)
Measured: 24 months
Change in expression of SLA
Fold change (FC)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start18 Mar 2017
- Primary completionDec 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar Ataxia Type 3Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura B. Jardim, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419974
- Sponsor's protocol ID
- 20170014
- Status last verified
- Jun 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be done via direct contact with the Principal Investigator in order to preserve individual participants identities
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Genetic Modifiers in a Study of Pre-ataxic and Ataxic SCA3/MJD Carriers (BIGPRO Study) - Astrocytes
- ClinicalTrials.gov ID
- NCT04419974
- Acronym / sponsor ID
- 20170014
- Conditions
- Spinocerebellar Ataxia Type 3, Machado-Joseph Disease, SCA3, MJD
- Keywords
- SCA3/MJD, SCA3, MJD, natural history, cytokines, astrocytes, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 18 Mar 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 9 Jun 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.
The study will consist of a prospective observation of subjects in a natural history design. The investigators will monitor changes of clinical scales, quality of life, messenger ribonucleic acid (mRNA) of candidate genes (CCL11, TNFSF14, FCGR3B, CLC, and SLA) (and their peptide products, when possible), and eotaxin and S100B serum levels, in order to determine which of them is (are) the most sensitive. Participants will be stratified in three groups: ataxic carriers, pre-ataxic carriers and non-carriers (controls).
Detailed description
Spinocerebellar ataxia type 3, or Machado-Joseph disease (SCA3/MJD), is an autosomal dominant neurodegenerative disorder caused by a CAG expansion at ATXN3. The gene product is a 42kDa protein called ataxin-3, widely expressed in neurons and peripheral tissues. Physiological roles of ataxin-3 include, at least, ubiquitination and regulation of misfolded proteins, cytoskeletal organization and focal adhesions development, and transcriptional regulation, most often as a transcriptional corepressor. One purpose of the present study is to detect a possible association between altered transcription patterns of candidate genes and disease progression. On the other hand, previous evidences suggest that the disease process linked to polyQ aggregation in neuronal cell ("cell-autonomous process") might be worsened by what happens outside the neuronal cell ("non-cell-autonomous process"). Initial evidences lead to the role of astrocytes. This is a major depart from the traditional understanding of polyglutamine diseases, and comprises the main focus of the present study.
The main hypothesis of this study is that the SCA3/MJD clinical features may be in part associated to astrocytic processes. In order to test it, peripheral level of LIGHT protein (encoded by TNFSF14) and eotaxin (encoded by CCL11) - both expressed in astrocytes -, and of S100B (a myelin damage marker), will be measured. The investigators speculate if they can be biomarkers of disease progression and of pathological process, even before symptoms onset. In case this is positive, their responsiveness to change will be tested to check if it is better than those of clinical scales.
The second aim is to test if disease progression can be associated with changes in the transcriptional pattern of candidate genes FCGR3B, CLC and SLA.
"BIGPRO study - Astrocytes" intends to identify variations in these candidates and validate them as SCA3/MJD biomarkers. The study will consist of a prospective observation of subjects in a natural history design. Changes in clinical scales, quality of life, messenger ribonucleic acid (mRNA) of candidate genes (CCL11, TNFSF14, FCGR3B, CLC, and SLA) (and their peptide products, when possible), and eotaxin and S100B serum levels will be monitored in order to determine which of them is (are) the most sensitive. Participants will be stratified in three groups: ataxic carriers, pre-ataxic carriers and non-carriers (controls). For each asymptomatic carrier, the time until start of disease will be estimated according to the individual CAG expanded sequence (CAGexp) and subject's age. Clinical scales Scale for the Assessment and Rating of Ataxia (SARA), Neurological Examination Scale for SCA (NESSCA), International Co-operative Rating Scale (ICARS), Inventory of Non-ataxia Symptoms (INAS), SCA Functional Index (SCAFI), Composite Cerebellar Functional Severity Score (CCFS) and Quality of Life measurements (EQ-5D and SF-36), will be applied at baseline, at 12 months and at 24 months, in all subjects (all three groups). Eotaxin, TNFSF14, S100B and mRNAs, will be measured in the same moments. Progression rates of all these variables will be estimated through mixed-models, including, as covariates, age, group and their interactions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ataxic carriers | – | Diagnostic Test: Clinical Scales - Baseline, Diagnostic Test: Blood Draw - Baseline, Diagnostic Test: Quality of Life Assessment - Baseline, Diagnostic Test: Clinical Scales - Follow-up 12 months, Diagnostic Test: Blood Draw - Follow-up 12 months, Diagnostic Test: Quality of Life Assessment - Follow-up 12 months, Diagnostic Test: Clinical Scales - Follow-up 24 months, Diagnostic Test: Blood Draw - Follow-up 24 months, Diagnostic Test: Quality of Life Assessment - Follow-up 24 monthsSubjects with a CAG repeat expansion on ATXN3 and Scale for Assessment and Rating of Ataxia (SARA) of 3 points or more. |
| Pre-ataxic carriers | – | Diagnostic Test: Molecular Diagnosis, Diagnostic Test: Clinical Scales - Baseline, Diagnostic Test: Blood Draw - Baseline, Diagnostic Test: Quality of Life Assessment - Baseline, Diagnostic Test: Clinical Scales - Follow-up 12 months, Diagnostic Test: Blood Draw - Follow-up 12 months, Diagnostic Test: Quality of Life Assessment - Follow-up 12 months, Diagnostic Test: Clinical Scales - Follow-up 24 months, Diagnostic Test: Blood Draw - Follow-up 24 months, Diagnostic Test: Quality of Life Assessment - Follow-up 24 monthsSubjects with a CAG repeat expansion on ATXN3 and Scale for Assessment and Rating of Ataxia (SARA) of less than 3 points. |
| Related controls | – | Diagnostic Test: Molecular Diagnosis, Diagnostic Test: Clinical Scales - Baseline, Diagnostic Test: Blood Draw - Baseline, Diagnostic Test: Quality of Life Assessment - Baseline, Diagnostic Test: Clinical Scales - Follow-up 12 months, Diagnostic Test: Blood Draw - Follow-up 12 months, Diagnostic Test: Quality of Life Assessment - Follow-up 12 months, Diagnostic Test: Clinical Scales - Follow-up 24 months, Diagnostic Test: Blood Draw - Follow-up 24 months, Diagnostic Test: Quality of Life Assessment - Follow-up 24 monthsSubjects without a CAG repeat expansion on ATXN3, but with a first degree relative affected by the disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with molecular diagnosis of SCA3/MJD will be recruited from the Medical Genetics Service database of Hospital de Clínicas de Porto Alegre, Brazil, by telephone calls or by invitation in the outpatient clinic. First degree relatives of these subjects at 50% risk of carrying the mutation will also be invited to participate.
Key inclusion criteria (2 listed)
- Individuals with molecular diagnosis of SCA3/MJD
- Individuals at 50% risk of inheriting SCA3/MJD mutation without any clinical manifestation
Key exclusion criteria (5 listed)
- Refusal to sign informed consent
- Other diagnosed neurological conditions;
- Diabetes Mellitus;
- Chronic allergy (asthma, eczema, urticaria)
- Eosinophilia on baseline
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 |
|---|---|---|
| Molecular DiagnosisDouble-blind molecular diagnosis for the SCA3/MJD mutation. | Diagnostic test | Pre-ataxic carriers, Related controls |
| Clinical Scales - BaselineSARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied on baseline. | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Blood Draw - BaselineBlood collection on baseline for evaluation of * Candidate genes expression * Serum proteins * Lymphocytic proteins | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Quality of Life Assessment - BaselineParticipants fill out 2 self-reported quality of life questionnaires. | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Clinical Scales - Follow-up 12 monthsSARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied 12 months after baseline for prospective evaluation. | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Blood Draw - Follow-up 12 monthsBlood collection 12 months after baseline for prospective evaluation of * Candidate genes expression * Serum proteins * Lymphocytic proteins | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Quality of Life Assessment - Follow-up 12 monthsParticipants fill out 2 self-reported quality of life questionnaires for prospective evaluation. | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Clinical Scales - Follow-up 24 monthsSARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied 24 months after baseline for prospective evaluation. | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Blood Draw - Follow-up 24 monthsBlood collection 24 months after baseline for prospective evaluation of * Candidate genes expression * Serum proteins * Lymphocytic proteins | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
| Quality of Life Assessment - Follow-up 24 monthsParticipants fill out 2 self-reported quality of life questionnaires for prospective evaluation. | Diagnostic test | Ataxic carriers, Pre-ataxic carriers, Related controls |
Primary outcome
Change in serum concentrations of Eotaxin
Time frame: 24 months
pg/ml
Change in serum concentrations of S100B
Time frame: 24 months
μg/l
Change in expression of TNFSF14
Time frame: 24 months
Fold change (FC)
Change in expression of CCL11
Time frame: 24 months
Fold change (FC)
Change in EQ-5D-3L (EuroQoL 5 Domains evaluated in 3 levels)
Time frame: 24 months
Quality of life scale evaluating 5 domains and a visual analog scale. Domain scores increase with worsening in quality of life. In the visual analog scale, worse scores mean decrease in quality of life.
Change in SF-36 (Short-form 36)
Time frame: 24 months
Quality of life scale evaluating 8 domains through 36 questions. Domain scores decrease with worsening in quality of life.
3 secondary outcomes
Change in expression of FCGR3B
Time frame: 24 months
Change in expression of CLC
Time frame: 24 months
Change in expression of SLA
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Official project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data sharing will be done via direct contact with the Principal Investigator in order to preserve individual participants identities
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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.
Laura B. Jardim, MD, PhD principal investigator
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?
An observational study of Spinocerebellar Ataxia Type 3 and Machado-Joseph Disease, 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 2 inclusion and 5 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 9 Jun 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. 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?
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 in serum concentrations of Eotaxin (time frame: 24 months). 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?
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 9 Jun 2020.