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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by MSDx, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541618
First Posted: March 1, 2012
Last Update Posted: March 1, 2012
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.
Information provided by (Responsible Party):
MSDx, Inc.
  Purpose
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.

Condition Intervention
Relapsing Remitting Multiple Sclerosis Other: MSDX Complex-1 Biomarker test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by MSDx, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Blood remaining after the biomarker test is completed will be retained for possible evaluation of additional biomarkers

Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Other: MSDX Complex-1 Biomarker test
MSDX Complex-1 Biomarker test
Other Name: Biomarker Test

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541618


Contacts
Contact: Marie Wesselhoft mwesselhoft@msdx.co
Contact: Ramesh Nayak, PhD rnayak@msdx.co

Locations
United States, Arizona
Northwest NeuroSpecialists, PLLC Recruiting
Tucson, Arizona, United States, 85741
Contact: Jeanette Wendt, MD    520-742-7890      
Principal Investigator: Jeanette Wendt, MD         
Sponsors and Collaborators
MSDx, Inc.
Investigators
Principal Investigator: Jeannette Wendt, MD Northwest NeuroSpecialists, PLLC
  More Information

Responsible Party: MSDx, Inc.
ClinicalTrials.gov Identifier: NCT01541618     History of Changes
Other Study ID Numbers: MSDX-0411
First Submitted: February 21, 2012
First Posted: March 1, 2012
Last Update Posted: March 1, 2012
Last Verified: February 2012

Keywords provided by MSDx, Inc.:
MS
RRMS
RR Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases