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A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01541618
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
MSDx, Inc.

Tracking Information
First Submitted Date February 21, 2012
First Posted Date March 1, 2012
Last Update Posted Date September 2, 2020
Actual Study Start Date January 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 29, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 29, 2012)
Gadolinium MRI and MSDX Complex-1 level [ Time Frame: 6 months ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Official Title A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Brief Summary The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers
Sampling Method Probability Sample
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).
Condition Relapsing Remitting Multiple Sclerosis
Intervention Other: MSDX Complex-1 Biomarker test
MSDX Complex-1 Biomarker test
Other Name: Biomarker Test
Study Groups/Cohorts 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).
Intervention: Other: MSDX Complex-1 Biomarker test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 29, 2012)
15
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Diagnosis of clinically definite relapsing remitting MS (RRMS)
  2. Age 45 years and older
  3. Willing and able to provide written informed consent
  4. Patient has high disease activity.
  5. Patient is about to begin Natalizumab (Tysabri) therapy.

Exclusion Criteria:

  1. Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS
  2. Known infectious or hematological disease.
  3. Unwilling or unable to comply with the requirements of this protocol
  4. Subject can not have a gadolinium enhanced MRI
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01541618
Other Study ID Numbers MSDX-0411
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MSDx, Inc.
Study Sponsor MSDx, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Jeannette Wendt, MD Northwest NeuroSpecialists, PLLC
PRS Account MSDx, Inc.
Verification Date February 2012