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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by MSDx, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
MSDx, Inc.
ClinicalTrials.gov Identifier:
NCT01541618
First received: February 21, 2012
Last updated: February 29, 2012
Last verified: February 2012

February 21, 2012
February 29, 2012
January 2012
July 2012   (final data collection date for primary outcome measure)
Change in MSDX Complex-1 between baseline and 6-month visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01541618 on ClinicalTrials.gov Archive Site
Gadolinium MRI and MSDX Complex-1 level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers

Probability Sample

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).

Relapsing Remitting Multiple Sclerosis
Other: MSDX Complex-1 Biomarker test
MSDX Complex-1 Biomarker test
Other Name: Biomarker Test
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact: Marie Wesselhoft mwesselhoft@msdx.co
Contact: Ramesh Nayak, PhD rnayak@msdx.co
United States
 
NCT01541618
MSDX-0411
No
MSDx, Inc.
MSDx, Inc.
Not Provided
Principal Investigator: Jeannette Wendt, MD Northwest NeuroSpecialists, PLLC
MSDx, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP