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

MSDx, Inc.

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Other: MSDX Complex-1 Biomarker test

Study type: Observational

Funder types: Industry

Identifiers

NCT01541618

MSDX-0411

Details and patient eligibility

About

The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.

Enrollment: 15 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Tysabri Group

Description:

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).

Treatment:

Other: MSDX Complex-1 Biomarker test