Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT01776060

Collaborator

(none)

Enrollment

Locations

92.6

Actual Duration (Months)

9.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to enroll 100 participants with Primary Progressive Multiple Sclerosis (PPMS) that have joined the MURDOCK Study Horizon 1.5 (Duke IRB Pro00011196) and the Multiple Sclerosis cohort (Duke IRB Pro00023791). All 100 participants will complete a biannual collection of a follow up questionnaire and blood/urine collection for a period of 5 years.

Condition or Disease	Intervention/Treatment	Phase
Primary Progressive Multiple Sclerosis	Other: generation of 'omic markers of disease progression

Detailed Description

Unlike Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS) in which patients experience a remission or lessening of their symptoms, Primary Progressive Multiple Sclerosis (PPMS) is characterized by progression of disability from onset, with no, or only occasional and minor, remissions and improvements. The age of onset for the primary progressive subtype is later than for the relapsing-remitting, but similar to mean the age of progression between the relapsing-remitting and the secondary progressive - around 40 years of age. Because of its prevalence, RRMS represents the largest basis for basic and clinical MS research. Therefore, drugs have primarily been developed to slow disease progression in RRMS and SPMS patients. No treatment has been proven successful in treating primary progressive MS.

The MURDOCK-MS collection represents a unique opportunity to carry out detailed biomarker research on PPMS patients and, to the knowledge of this investigator and his colleagues in the field, would represent an exceptional cohort that is not available elsewhere in the US or the rest of the world. Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Serial Collection of Primary Progressive Multiple Sclerosis Participants in the MURDOCK Study

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Sep 21, 2020

Actual Study Completion Date :

Sep 21, 2020

Outcome Measures

Primary Outcome Measures

Generation of 'omic markers of disease progression [5 years]
Biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression. This progressive etiology would provide valuable insight into PPMS development and may also shed light on SPMS progression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Enrolled in the MURDOCK Study Horizon 1.5 (Pro00011196)
Enrolled in the Multiple Sclerosis Cohort (Pro00023791)
Diagnosed with Primary Progressive Multiple Sclerosis
At least 18 years of age

Exclusion Criteria:

Participants not willing to participate or sign informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NE Neurology	Concord	North Carolina	United States	28025
2	The Stedman Center on the Duke Center for Living Campus	Durham	North Carolina	United States	27705
3	Raleigh Neurology Associates	Raleigh	North Carolina	United States	27607