Relapsing Remitting Multiple SclerosisNCT01541618
A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
An observational study of Relapsing Remitting Multiple Sclerosis, run by MSDx, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- MSDX Complex-1 Biomarker test
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study populations for this study is a patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).
Who may be able to join
- Diagnosis of clinically definite relapsing remitting MS (RRMS)
- Age 45 years and older
- Willing and able to provide written informed consent
- Patient has high disease activity.
- Patient is about to begin Natalizumab (Tysabri) therapy.
Who cannot join
- Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS
- Known infectious or hematological disease.
- Unwilling or unable to comply with the requirements of this protocol
- Subject can not have a gadolinium enhanced MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741
About this study
Official title: A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- MSDX Complex-1 Biomarker test
- Keywords
- MS, RRMS, RR Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSDX Complex-1 Biomarker testOther
Also called Biomarker Test
MSDX Complex-1 Biomarker test
| Study group | Role | What they receive |
|---|---|---|
| Tysabri Group | Patients with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). Receives: Other: MSDX Complex-1 Biomarker test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MSDX Complex-1 between baseline and 6-month visit
This outcome measure will evaluate a difference in the level of MSDX Complex-1 form the baseline visit to the 6-month visit. MSDX Complex-1 is a biomarker for MS disease activity and its change should correspond with a change in the disease activity in MS.
Measured: 6 months
Secondary outcomes (1)
Gadolinium MRI and MSDX Complex-1 level
This outcome will evaluate whether a change seen in a Gadolinium MRI (a diagnostic test for MS) matches with a change in the MSDX Complex-1 level in a patient with MS.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeannette Wendt, MD, Principal investigator, Northwest NeuroSpecialists, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541618
- Sponsor's protocol ID
- MSDX-0411
- Status last verified
- Feb 2012
- First submitted
- 21 Feb 2012
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01541618
- Acronym / sponsor ID
- MSDX-0411
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- MS, RRMS, RR Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MSDx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Mar 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.
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tysabri Group | – | Other: MSDX Complex-1 Biomarker testPatients with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations for this study is a patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).
Key inclusion criteria (5 listed)
- Diagnosis of clinically definite relapsing remitting MS (RRMS)
- Age 45 years and older
- Willing and able to provide written informed consent
- Patient has high disease activity.
- Patient is about to begin Natalizumab (Tysabri) therapy.
Key exclusion criteria (4 listed)
- Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS
- Known infectious or hematological disease.
- Unwilling or unable to comply with the requirements of this protocol
- Subject can not have a gadolinium enhanced MRI
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 |
|---|---|---|
| MSDX Complex-1 Biomarker testAlso: Biomarker TestMSDX Complex-1 Biomarker test | Other | Tysabri Group |
Primary outcome
Change in MSDX Complex-1 between baseline and 6-month visit
Time frame: 6 months
This outcome measure will evaluate a difference in the level of MSDX Complex-1 form the baseline visit to the 6-month visit. MSDX Complex-1 is a biomarker for MS disease activity and its change should correspond with a change in the disease activity in MS.
1 secondary outcome
Gadolinium MRI and MSDX Complex-1 level
Time frame: 6 months
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 2 Sep 2020.
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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.
Jeannette Wendt, MD principal investigator
Northwest NeuroSpecialists, PLLC
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 Relapsing Remitting Multiple Sclerosis, run by MSDx, Inc. 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 5 inclusion and 4 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 2 Sep 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 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?
Change in MSDX Complex-1 between baseline and 6-month visit (time frame: 6 months). 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 2 Sep 2020.