Multiple SclerosisNCT04133779
Observational Study on Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Fondazione Italiana Sclerosi Multipla.
Trial summary
This is a multicentre observational study which involves 43 of the major Italian centres that treat MS. The duration expected for the study participation of each subject was exclusively the necessary one for the screening visit and execution of the ecocolor-Doppler test, which could have also been executed on the same… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler, neurological evaluation, ecocolor-Doppler and medical history, vital signs, ecocolor-Doppler
- Type of treatment
- Surgery or procedure
- How many people
- 1,767 participants
- Where
- No sites listed yet
- Study dates
- 29 Dec 2010to 30 May 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
- No healthy volunteers
- Adult
Study population: Subjects aged 18-55 years, non-gender based, non-sex based.
Who may be able to join
- Group A (MS)
- Age 18-55 years;
- Unisex patients diagnosed with MS according to McDonald criteria and successive relapse (38, 39), and subjects with CIS;
- Course of the disease: RR-SP-PP-CIS;
- Disease duration (starting from diagnosis): from 1 month to 25 years for subjects with RR, SP, and PP; a maximum of 5 years for subjects with CIS;
- Not in clinical relapse (at least 30 days after the last clinical relapse);
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- Subjects treated or non-treated with immunomodulatory and immunosuppressive drugs;
- Signature of the informed consent.
- Group B (HC)
- Age 18-55 years;
- Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC);
- Signature of the informed consent.
- The subjects included in this group could be, for example, unrelated relatives or spouses of those affected by MS or other diseases in the study or linked to these by affinity restrictions (such as, the father-in-law with the son-in-law, the husband with his wife's brother, etc.) or accompanying persons or operators of other centres.
- Group C (OND)
- Aged 18-55 years;
- Subjects with other non-inflammatory neurodegenerative disease (OND), for example Parkinson, ALS, ataxy.
- Group D (ONDi)
- Age 18-55 years;
- subjects suffering of other inflammatory neurodegenerative diseases (ONDi), for example optical neuromielitys, ADEM, encephalitis, neuro lupus, neurological complications of systemic autoimmune diseases;
- Signature of the informed consent.
Who cannot join
- • The presence of acute or chronic disease which are disabling or interfere with the design and objective of the study;
- Clinically proven cardiopathy (NYHA ≥ I class);
- Previous episodes of venal thromboembolism (including either deep venal thrombosis or pulmonary embolism);
- Neoplasms;
- Thrombophilia from an anamnestic definition;
- Diabetes;
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- Primary or secondary pulmonary hypertension and in treatment for it;
- Concurrent systemic steroid treatments or in the last 30 days;
- Cerebrovascular diseases current or previous;
- Episodes of global transitory amnesia;
- Pregnancy.
About this study
Official title: Multiple Sclerosis
This is a multicentre observational study which involves 43 of the major Italian centres that treat MS. The duration expected for the study participation of each subject was exclusively the necessary one for the screening visit and execution of the ecocolor-Doppler test, which could have also been executed on the same day.
- Conditions
- Multiple Sclerosis
- Being tested
- neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler, neurological evaluation, ecocolor-Doppler, medical history, vital signs, ecocolor-Doppler
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-DopplerProcedure or surgery
For the subjects diagnosed with MS (group A), who did not need to be in a period of clinical relapse of the disease (at least 30 days from the last clinical relapse), the duration and the form of the disease was indicated (CIS, RR, SP or PP). The Investigator has submitted these subjects to a neurological examination which included the standard neurological examination, the Kurtzke EDSS (Kurtzke Expanded Disability Status Scale) comprising the functional systems of Kurtzke and the Barthel scale. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.
neurological evaluation, ecocolor-DopplerProcedure or surgery
For the subjects affected by OND and ONDi, as in the groups C and D respectively, the Investigator has performed, beside the anamnesis and the physical examination, a specific neurological evaluation which included the compilation of the Barthel scale for the disability evaluation. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for performing the ecocolor-Doppler examination which was performed in blind.
medical history, vital signs, ecocolor-DopplerProcedure or surgery
For the healthy subjects (HC) of the group B, the Investigator has solely performed the medical history and a check of the vital signs, reporting the demographic and clinical data of the subjects. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.
| Study group | Role | What they receive |
|---|---|---|
| Group A (MS) | * Age 18-55 years;
* Unisex patients diagnosed with MS according to McDonald criteria and successive relapse (38, 39), and subjects with CIS;
* Course of the disease: RR-SP-PP-CIS;
* Disease duration (starting from diagnosis): from 1 month to 25 years for subjects with RR, SP, and PP; a maximum of 5 years for subjects with CIS;
* Not in clinical relapse (at least 30 days after the last clinical relapse);
* Subjects treated or non-treated with immunomodulatory and immunosupressive drugs;
* Signature of the informed consent. Receives: Procedure: neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler | |
| Group B (HC) | * Age 18-55 years;
* Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC);
* Signature of the informed consent.
The subjects included in this group could be, for example, unrelated relatives or spouses of those affected by MS or other diseases in the study, or linked to these by affinity restrictions (such as, the father-in-law with the son-in-law, the husband with his wife's brother, etc.) or accompanying persons or operators of other centres. Receives: Procedure: medical history, vital signs, ecocolor-Doppler | |
| Group C (OND) | * Aged 18-55 years;
* Subjects with other non-inflammatory neurodegenerative disease (OND), for example Parkinson, ALS, ataxy.
* Signature of the informed consent. Receives: Procedure: neurological evaluation, ecocolor-Doppler | |
| Group D (ONDi) | * Age 18-55 years;
* subjects suffering of other inflammatory neurodegenerative diseases (ONDi), for example optical neuromielitys, ADEM, encephalitis, neuro lupus, neurological complications of systemic autoimmune diseases;
* Signature of the informed consent. Receives: Procedure: neurological evaluation, ecocolor-Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of CCSVI
The protocol provided that the presence of CCSVI was evaluated according to the Zamboni criteria at local level. Therefore, the ecocolor-Doppler images were sent in a randomized process to a central assessor who performed the first centralized reading. In case of disagreement with the local reading, the same images were to be sent to other two central readers, preserving the anonymity, in order to obtain a final evaluation in regards to the CCSVI presence.
Measured: 29.12.2010-30.05.2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start29 Dec 2010
- Primary completion30 May 2012
- Study completion30 May 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sclerosi Multipla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133779
- Sponsor's protocol ID
- FondazioneISM
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04133779
- Acronym / sponsor ID
- FondazioneISM
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,767 participants (actual)
- Lead sponsor
- Fondazione Italiana Sclerosi MultiplaUniversity, hospital or other
- Study start
- 29 Dec 2010 (actual)
- Primary completion
- 30 May 2012 (actual)
- Study completion
- 30 May 2012 (actual)
- First posted
- 21 Oct 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.
This is a multicentre observational study which involves 43 of the major Italian centres that treat MS. The duration expected for the study participation of each subject was exclusively the necessary one for the screening visit and execution of the ecocolor-Doppler test, which could have also been executed on the same day.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (MS) | – | Procedure: neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler* Age 18-55 years; * Unisex patients diagnosed with MS according to McDonald criteria and successive relapse (38, 39), and subjects with CIS; * Course of the disease: RR-SP-PP-CIS; * Disease duration (starting from diagnosis): from 1 month to 25 years for subjects with RR, SP, and PP; a maximum of 5 years for subjects with CIS; * Not in clinical relapse (at least 30 days after the last clinical relapse); * Subjects treated or non-treated with immunomodulatory and immunosupressive drugs; * Signature of the informed consent. |
| Group B (HC) | – | Procedure: medical history, vital signs, ecocolor-Doppler* Age 18-55 years; * Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC); * Signature of the informed consent. The subjects included in this group could be, for example, unrelated relatives or spouses of those affected by MS or other diseases in the study, or linked to these by affinity restrictions (such as, the father-in-law with the son-in-law, the husband with his wife's brother, etc.) or accompanying persons or operators of other centres. |
| Group C (OND) | – | Procedure: neurological evaluation, ecocolor-Doppler* Aged 18-55 years; * Subjects with other non-inflammatory neurodegenerative disease (OND), for example Parkinson, ALS, ataxy. * Signature of the informed consent. |
| Group D (ONDi) | – | Procedure: neurological evaluation, ecocolor-Doppler* Age 18-55 years; * subjects suffering of other inflammatory neurodegenerative diseases (ONDi), for example optical neuromielitys, ADEM, encephalitis, neuro lupus, neurological complications of systemic autoimmune diseases; * Signature of the informed consent. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects aged 18-55 years, non-gender based, non-sex based.
Key inclusion criteria (20 listed)
- Group A (MS)
- Group B (HC)
- Age 18-55 years;
- Absence of significant diseases and lack of familiarity with MS, ie health check-ups (HC);
- Signature of the informed consent.
Key exclusion criteria (11 listed)
- • The presence of acute or chronic disease which are disabling or interfere with the design and objective of the study;
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 |
|---|---|---|
| neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-DopplerFor the subjects diagnosed with MS (group A), who did not need to be in a period of clinical relapse of the disease (at least 30 days from the last clinical relapse), the duration and the form of the disease was indicated (CIS, RR, SP or PP). The Investigator has submitted these subjects to a neurological examination which included the standard neurological examination, the Kurtzke EDSS (Kurtzke Expanded Disability Status Scale) comprising the functional systems of Kurtzke and the Barthel scale. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind. | Procedure or surgery | Group A (MS) |
| neurological evaluation, ecocolor-DopplerFor the subjects affected by OND and ONDi, as in the groups C and D respectively, the Investigator has performed, beside the anamnesis and the physical examination, a specific neurological evaluation which included the compilation of the Barthel scale for the disability evaluation. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for performing the ecocolor-Doppler examination which was performed in blind. | Procedure or surgery | Group C (OND), Group D (ONDi) |
| medical history, vital signs, ecocolor-DopplerFor the healthy subjects (HC) of the group B, the Investigator has solely performed the medical history and a check of the vital signs, reporting the demographic and clinical data of the subjects. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind. | Procedure or surgery | Group B (HC) |
Primary outcome
The presence of CCSVI
Time frame: 29.12.2010-30.05.2012
The protocol provided that the presence of CCSVI was evaluated according to the Zamboni criteria at local level. Therefore, the ecocolor-Doppler images were sent in a randomized process to a central assessor who performed the first centralized reading. In case of disagreement with the local reading, the same images were to be sent to other two central readers, preserving the anonymity, in order to obtain a final evaluation in regards to the CCSVI presence.
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 21 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fondazione Italiana Sclerosi Multipla.
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 11 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The presence of CCSVI (time frame: 29.12.2010-30.05.2012). 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 21 Oct 2019.