A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01539395
• Other study ID #: MSDX0211
• Status: Withdrawn
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2020
• Source: MSDx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Age 45 years or older of either gender and of any racial/ethnic group.

2. Subjects must be in generally good health.

3. Subjects must be able and willing to comply with the requirements of the protocol.

4. Must be diagnosed with RRMS

5. Meets the criteria to enter Group 1 or Group 2

Exclusion Criteria:

1. Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)

2. Subject currently has a condition such as active influenza that would stimulate the immune system

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MSDx Complex-1 Biomarker Test
A biomarker test for the level of MSDx Complex-1

Locations

Country	Name	City	State
United States	Northwest NeuroSpecialists, PLLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MSDx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker Differential	A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse	Baseline
Secondary	Biomarker reduction with steroid therapy	A decrease in the level of MSDx Complex-1 in response to steroid therapy for a relapse of MS.	3 months