Multiple SclerosisNCT01737372
A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
An observational study of Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by John F. Foley, MD at 1 site in United States.
Trial summary
This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Oct 2016
- 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 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 45 participants will be enrolled into a study to examine the microRNA and cell products profile in both cerebrospinal fluid (CSF) and blood. Study population will consist of a total of: 20 CIS patients defined as patients having a single attack (or the appearance of one or more symptoms characteristic of MS) high risk of developing MS, when no other diseases or causes are apparent. 20 SPMS patients 5 normal, non-diseased controls
Who may be able to join
- able to understand and agree to informed consent;
- male or female patients 18-68 years of age
- no disease modifying therapy 60 days prior to Baseline
- EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient
- Labs within normal range no greater than 2 times the ULN or at the discretion of the PI
- weight 46 kilograms to 127 kilograms inclusive
Show all 9Show fewer
- no active systemic infection
- not currently pregnant or breast feeding
- no history of corticosteroid treatment or relapse within 60 days prior to Baseline.
Who cannot join
- not able to understand informed consent
- if any of the inclusion criteria is not met
- HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB
- positive pregnancy test
- patient withdraws consent
- Coumadin use within 60 days prior to Baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103
About this study
This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.
Read the detailed description
Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.
This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.
- Conditions
- Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
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 |
|---|---|---|
| Secondary Progressive MS (SPMS) | Secondary Progressive MS participants | |
| Clinically Isolated Syndrome (CIS) | Clinically isolated syndrome participants | |
| Healthy participants | No immunological or neurological illnesses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.
Measured: baseline
Secondary outcomes (1)
Correlate microRNA profiles with clinical and CSF inflammation indexes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2016
- Study completionOct 2016
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
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- John F. Foley, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor-investigator, John F. Foley, MD, Rocky Mountain MS Research Group, LLC
- Investigators
- John F Foley, MD, Principal investigator, Rocky Mountain MS Research Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737372
- Sponsor's protocol ID
- 003-001-GEN
- Status last verified
- Nov 2016
- First submitted
- 27 Nov 2012
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01737372
- Acronym / sponsor ID
- 003-001-GEN
- Conditions
- Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- John F. Foley, MDUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Nov 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Nov 2012 (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.
This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.
Detailed description
Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.
This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secondary Progressive MS (SPMS) | – | –Secondary Progressive MS participants |
| Clinically Isolated Syndrome (CIS) | – | –Clinically isolated syndrome participants |
| Healthy participants | – | –No immunological or neurological illnesses. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 45 participants will be enrolled into a study to examine the microRNA and cell products profile in both cerebrospinal fluid (CSF) and blood. Study population will consist of a total of: 20 CIS patients defined as patients having a single attack (or the appearance of one or more symptoms characteristic of MS) high risk of developing MS, when no other diseases or causes are apparent. 20 SPMS patients 5 normal, non-diseased controls
Key inclusion criteria (9 listed)
- able to understand and agree to informed consent;
- male or female patients 18-68 years of age
- no disease modifying therapy 60 days prior to Baseline
- EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient
- Labs within normal range no greater than 2 times the ULN or at the discretion of the PI
Key exclusion criteria (6 listed)
- not able to understand informed consent
- if any of the inclusion criteria is not met
- HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB
- positive pregnancy test
- patient withdraws consent
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
To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.
Time frame: baseline
1 secondary outcome
Correlate microRNA profiles with clinical and CSF inflammation indexes
Time frame: baseline
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 9 Nov 2016.
- Individual participant dataSharing planned: No
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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.
John F Foley, MD principal investigator
Rocky Mountain MS Research Group, LLC
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 Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by John F. Foley, MD at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 9 Nov 2016. 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 United States. 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?
To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. (time frame: baseline). 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 Nov 2016.