Multiple SclerosisCOSMONCT01384825
Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases
An observational study of Multiple Sclerosis and Neurodegenerative Diseases, run by Fondazione Italiana Sclerosi Multipla at 43 sites in 2 countries.
Trial summary
The presence of abnormalities in the cerebral venous circulation, defined as Chronic Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological diseases. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Neurodegenerative Diseases
- How many people
- 200 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Dec 2010to Oct 2012
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.
Who may be able to join
- Group A (MS)
- Age: 18 to 55;
- Subjects of either sex with a diagnosis of MS according to McDonald's criteria and subsequent revisions (38, 39) and patients with CIS;
- Course of the disease: RR - SP - PP - CIS;
- Duration of the disease: from 1 month to 25 years for RR, SP and PP subjects; 5 years at most for the subjects with CIS,
- Not in a period of clinical relapsing of the disease (at least 30 days since the last clinical relapse),
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- Subjects treated or not with immunomodulating and immunosuppressive drugs;
- Signature of the informed consent form.
- Group B (HC)
- Age: 18 to 55;
- No significant diseases and no familiarity for MS, that is to say healthy controls (HC);
- Signature of the informed consent form. The subjects included in this group may be, for instance, non-blood relatives or spouses of the subjects with MS or with any of the other diseases being studied, or be linked to them by ties of affinity (e.g. a son-in-law with a father-in-law, a husband with his wife's brother, etc.) or accompanying persons or operators from other Sites.
- Group C (OND)
- Age: 18 to 55 ;
- Subjects with other non-inflammatory neurodegenerative diseases (OND) such as, by way of example, Parkinson's disease, amyotrophic lateral sclerosis (ALS) and heredoataxia.
- Signature of the informed consent form.
- Group D (ONDi)
- Age: 18 - 55
- Patients with other inflammatory neurodegenerative diseases (ONDi) such as, by way of example, optical neuromyelitis (ONM), acute disseminated encephalomyelitis (ADEM), encephalitis, neurolupus, neurological complications of systemic autoimmune diseases.
- Signature of the informed consent form.
Who cannot join
- Presence of acute or chronic diseases of an invalidating nature or that could interfere with the design and aims of the study;
- Clinically ascertained heart disease (New YOrk Heart AssoCiation (NYHA) Class ≥ I).
- Past episodes of venous thromboembolism (including both Deep Vein Thrombosis and lung embolism).
- Tumours.
- Thrombophilia as defined in the case history.
- Diabetes.
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- Primitive or secondary pulmonary hypertension and related treatment.
- Concomitant systemic steroid treatment or in the last 30 days.
- Current or past cerebrovascular disease.
- Episodes of Transient Global Amnesia (TGA).
- Obvious pregnancy.
- Past diagnosis of CCSVI or earlier treatment for CCSVI.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
Italy42 sites
Azienda Ospedali Riuniti - Div. di Neurologia - Centro Studi Sclerosi Multipla
Ancona, 60126
Università di Bari - Ospedale Consorziale Policlinico - Dip. Scienze Neurologiche e Psichiatriche
Bari, 70124
Azienda USL Città di Bologna - Distretto Santo Stefano Savena - Centro Sclerosi Multipla
Bologna, 40141
Azienda Ospedaliera Spedali Civili Presidio Montichiari - Centro Studi Sclerosi Multipla
Brescia, 25012
Università degli Studi di Cagliari - Centro Sclerosi Multipla - Ospedale Binaghi
Cagliari, 09126
Azienda Ospedaliera "Garibaldi" - U.O. Neurologia
Catania, 95122
Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele" - Istituto Scienze Neurologiche
Catania, 95123
Istituto San Raffaele Giuseppe Giglio - Centro Sclerosi Multipla
Cefalù, 90015
Ospedale Universitario G. D'Annunzio - Centro Sclerosi Multipla
Chieti, 66013
Azienda Ospedaliera San Giuseppe - Centro Scl. Multipla - U.O. Neurologia
Empoli, 50053
Università degli Studi di Ferrara Arcispedale Sant'Anna - Clinica Neurologica
Ferrara, 44100
Università degli Studi di Ferrara Arcispedale Sant'Anna - Istituto di Clinica Neurologica
Ferrara, 44100
Azienda Ospedaliero Universitaria Careggi - Centro di Riferimento Regionale per la Sclerosi Multipla
Florence, 50134
Azienda Ospedaliero Universitaria Careggi - Centro Sclerosi Multipla
Florence, 50134
Azienda Ospedaliera Universitaria Ospedali Riuniti - Centro Sclerosi Multipla
Foggia, 71122
Ospedale S. Antonio Abate - Centro Studi Sclerosi Multipla
Gallarate, 21013
Azienda Ospedaliera Universitaria San Martino
Genova, 16132
Ospedale S. Andrea - Divisione di Neurologia
La Spezia, 19124
Ospedale Tappeiner - Div. Neurologica
Merano, 39012
IRCCS Centro Studi Neurolesi "Bonino Pulejo" di Messina
Messina, 98121
Azienda Ospedaliera Universitaria "G. Martino" - Dipartimento Neuroscienze Psichiatria e Anestesiologia
Messina, 98125
Università degli Studi di Milano - Dipartimento di Neurologia - Ospedale S. Raffaele - Via Olgettina , 60
Milan, 20132
Fondazione Ist. Neurologico Besta - Centro Sclerosi Multipla
Milan, 20133
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente - Unità Operativa Sclerosi Multipla
Milan, 20148
Ospedale Niguarda Cà Granda - Centro Sclerosi Multipla
Milan, 20162
Università Federico II - Clinica Neurologica II
Naples, 80131
Azienda Ospedaliera S. Luigi - Centro Sclerosi Multipla - Divisione Universitaria di Neurologia
Orbassano, 10043
Policlinico Az. Ospedaliera - Clinica Neurologica I
Padova, 35128
Università degli Studi di Palermo - Istituto di Neuropsichiatria - A.O.U.P. "P. Giaccone"
Palermo, 90129
Azienda Ospedaliera Villa Sofia C.T.O. - Neurologia Padiglione Geriatrico
Palermo, 90146
Istituto Neurologico C. Mondino - Divisione di Neurologia
Pavia, 27100
Arciospedale S. Maria Nuova - Centro Studi Sclerosi Multipla
Reggio Emilia, 42100
Università Tor Vergata - Clinica Neurologica - Dipartimento di Neuroscienze
Roma, 00133
Ospedale Sant'Andrea - Neurologia e Centro Neurologico Terapie Sperimentali
Roma, 00189
Università di Sassari - Clinica Neurologica
Sassari, 07100
Università degli Studi di Siena - Dip. di Neuroscienze - Sez. Neurologia
Siena, 53100
Università degli Studi di Siena - Dip. di Neuroscienze - U.O. Neurologia e Malattie Neurometaboliche
Siena, 53100
Azienda Ospedaliera Universitaria S. Giovanni Battista - Centro Sclerosi Multipla - Dipartimento di Neuroscienze
Torino, 10126
Azienda Ospedaliera "Ca Foncello" - Dipartimento di Neuroscienze - U.O. Neurologia
Treviso, 31100
Ospedale di Cattinara - Istituto Clinica Neurologica
Trieste, 34149
Ospedale S. Bortolo - Divisione di Neurologia - Centro Sclerosi Multipla
Vicenza, 36100
Azienda Sanitaria Provinciale di Ragusa Ospedale "R. Guzzardi" - U.O.C. Neurologia e Neurofisiopatologia, Stroke Unit
Vittoria, 97019
Romania1 site
Opera Contract Research Organization SRL
Timișoara, Timiș County, 300209
About this study
The presence of abnormalities in the cerebral venous circulation, defined as Chronic Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease.
In the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system.
Read more
This is an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of Healthy Controls (HC) and in a population affected by other neurological diseases of the central nervous system of degenerative, vascular, inflammatory and autoimmune origin.
A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.
Read the detailed description
It has been recently reported the possible presence of abnormalities in the cerebral venous circulation of people with MS, in healthy controls and in people with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease. In particular, the studies by Zamboni and colleagues (Ferrara University) and by Zivadinov and colleagues (University of Buffalo) have suggested an association between CCSVI and MS that was widely reported by the mass media world-wide.
It can be noted that in the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system. The recent and authoritative contributions from the scientific community involved with MS stressing the need for closely controlled and suitably designed clinical studies for investigating the hypotheses suggested with regard to CCSVI (with the necessary thoroughness and with the promptness demanded by the public opinion) are therefore definitely justified.
The possibility that there may be a new pathogenic mechanism underlying the development of MS, not in line with the majority of the experimental data concerning the aetiopathogenesis of this disease, has produced a strong echo throughout the scientific community. Increasingly, in recent months, both the working groups mentioned above and new authors have developed further research studies in order to confirm and extend the results obtained and to lay scientifically sound foundations for possible therapeutic applications for this discovery.
The Fondazione Italiana Sclerosi Multipla (FISM) Onlus, in its capacity as Promoter of this study, wishes, responsibly, to produce the best possible answer for people with MS all over the world. It therefore feels that it is necessary to proceed with the utmost scientific thoroughness, initially by means of a large-scale sample study for evaluating the prevalence of venous abnormalities in MS compared with that observed in normal controls and in controls with other diseases of the nervous system. In this context, the features of this study that distinguish it from previous studies and from the current state of knowledge are the following:
- Blind multi-Site observational study using the Echo-Color-Doppler equipment assigned to the study;
- Size of the sample with MS, of at least 1200 study subjects;
- Evaluation of the prevalence of CCSVI and of other malformations of the venous haemodynamics in the Clinically Isolated Syndrome (CIS), Relapsing-Remitting (RR), Primary Progressive (PP) and Secondary Progressive (SP) forms of MS, using a larger sample than those involved up to the present time.
In this observational study, the prevalence of CCSVI and of other malformations of the venous haemodynamics will be evaluated in different forms of MS and in other diseases of the nervous system. This is therefore an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of healthy subjects and in a population of people with other neurological diseases of the central and peripheral nervous system of degenerative, vascular, inflammatory and autoimmune origin.
The study is a multi-Site observational study. A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.
- Conditions
- Multiple Sclerosis, Neurodegenerative Diseases
- Keywords
- Multiple Sclerosis, Other Neurodegenerative Diseases, Chronic CerebroSpinal Venous Insufficiency, Prevalence, Case-control
- Medical subject headings
- Multiple Sclerosis, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS | Subjects with Multiple Sclerosis | |
| HC | Healthy Controls | |
| OND | Subjects with Other Neurodegenerative Diseases, including both other non-inflammatory neurodegenerative diseases ("OND") and other inflammatory neurodegenerative diseases ("ONDi") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CCSVI
The prevalence of CCSVI in MS (overall and in its various different forms) will be estimated, with 95% confidence intervals, and compared with that of the other groups. The differences in the prevalence of CCSVI between the various groups will be evaluated using the chi-square test. The sensitivity, specificity and accuracy of the method will be estimated with their 95% confidence intervals. Values of p equal to or lower than 0.05 will be considered significant.
Measured: The primary outcome will be assessed at enrollment (day 1). No follow-up is planned.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sclerosi Multipla
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Giovanni L Mancardi, MD, Principal investigator, Università di Genova - Dipartimento di Neuroscienze, Oftalmologia e Genetica - Via De Toni, 5 - GenovaGiancarlo Comi, Principal investigator, Divisione di Neurologia e Servizio di Neurofisiologia, Ospedale San Raffaele di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384825
- Sponsor's protocol ID
- FISM 2010R1
- Acronym
- COSMO
- Status last verified
- Jan 2018
- First submitted
- 27 Jun 2011
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT01384825
- Acronym / sponsor ID
- COSMO / FISM 2010R1
- Conditions
- Multiple Sclerosis, Neurodegenerative Diseases
- Keywords
- Multiple Sclerosis, Other Neurodegenerative Diseases, Chronic CerebroSpinal Venous Insufficiency, Prevalence, Case-control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondazione Italiana Sclerosi MultiplaUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- Dec 2010 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Jun 2011 (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.
The presence of abnormalities in the cerebral venous circulation, defined as Chronic Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease.
In the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system.
This is an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of Healthy Controls (HC) and in a population affected by other neurological diseases of the central nervous system of degenerative, vascular, inflammatory and autoimmune origin.
A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.
Detailed description
It has been recently reported the possible presence of abnormalities in the cerebral venous circulation of people with MS, in healthy controls and in people with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease. In particular, the studies by Zamboni and colleagues (Ferrara University) and by Zivadinov and colleagues (University of Buffalo) have suggested an association between CCSVI and MS that was widely reported by the mass media world-wide.
It can be noted that in the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system. The recent and authoritative contributions from the scientific community involved with MS stressing the need for closely controlled and suitably designed clinical studies for investigating the hypotheses suggested with regard to CCSVI (with the necessary thoroughness and with the promptness demanded by the public opinion) are therefore definitely justified.
The possibility that there may be a new pathogenic mechanism underlying the development of MS, not in line with the majority of the experimental data concerning the aetiopathogenesis of this disease, has produced a strong echo throughout the scientific community. Increasingly, in recent months, both the working groups mentioned above and new authors have developed further research studies in order to confirm and extend the results obtained and to lay scientifically sound foundations for possible therapeutic applications for this discovery.
The Fondazione Italiana Sclerosi Multipla (FISM) Onlus, in its capacity as Promoter of this study, wishes, responsibly, to produce the best possible answer for people with MS all over the world. It therefore feels that it is necessary to proceed with the utmost scientific thoroughness, initially by means of a large-scale sample study for evaluating the prevalence of venous abnormalities in MS compared with that observed in normal controls and in controls with other diseases of the nervous system. In this context, the features of this study that distinguish it from previous studies and from the current state of knowledge are the following:
- Blind multi-Site observational study using the Echo-Color-Doppler equipment assigned to the study;
- Size of the sample with MS, of at least 1200 study subjects;
- Evaluation of the prevalence of CCSVI and of other malformations of the venous haemodynamics in the Clinically Isolated Syndrome (CIS), Relapsing-Remitting (RR), Primary Progressive (PP) and Secondary Progressive (SP) forms of MS, using a larger sample than those involved up to the present time.
In this observational study, the prevalence of CCSVI and of other malformations of the venous haemodynamics will be evaluated in different forms of MS and in other diseases of the nervous system. This is therefore an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of healthy subjects and in a population of people with other neurological diseases of the central and peripheral nervous system of degenerative, vascular, inflammatory and autoimmune origin.
The study is a multi-Site observational study. A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MS | – | –Subjects with Multiple Sclerosis |
| HC | – | –Healthy Controls |
| OND | – | –Subjects with Other Neurodegenerative Diseases, including both other non-inflammatory neurodegenerative diseases ("OND") and other inflammatory neurodegenerative diseases ("ONDi") |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.
Key inclusion criteria (20 listed)
- Group A (MS)
- Age: 18 to 55;
- Subjects of either sex with a diagnosis of MS according to McDonald's criteria and subsequent revisions (38, 39) and patients with CIS;
- Course of the disease: RR - SP - PP - CIS;
- Duration of the disease: from 1 month to 25 years for RR, SP and PP subjects; 5 years at most for the subjects with CIS,
Key exclusion criteria (12 listed)
- Presence of acute or chronic diseases of an invalidating nature or that could interfere with the design and aims of the study;
- Clinically ascertained heart disease (New YOrk Heart AssoCiation (NYHA) Class ≥ I).
- Past episodes of venous thromboembolism (including both Deep Vein Thrombosis and lung embolism).
- Tumours.
- Thrombophilia as defined in the case history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of CCSVI
Time frame: The primary outcome will be assessed at enrollment (day 1). No follow-up is planned.
The prevalence of CCSVI in MS (overall and in its various different forms) will be estimated, with 95% confidence intervals, and compared with that of the other groups. The differences in the prevalence of CCSVI between the various groups will be evaluated using the chi-square test. The sensitivity, specificity and accuracy of the method will be estimated with their 95% confidence intervals. Values of p equal to or lower than 0.05 will be considered significant.
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 Jan 2018.
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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.
Giovanni L Mancardi, MD principal investigator
Università di Genova - Dipartimento di Neuroscienze, Oftalmologia e Genetica - Via De Toni, 5 - Genova
Giancarlo Comi principal investigator
Divisione di Neurologia e Servizio di Neurofisiologia, Ospedale San Raffaele di Milano
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neurodegenerative Diseases, run by Fondazione Italiana Sclerosi Multipla at 43 sites in 2 countries.
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 20 inclusion and 12 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Italy, Romania. 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?
Prevalence of CCSVI (time frame: The primary outcome will be assessed at enrollment (day 1). No follow-up is planned.). 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 16 Jan 2018.