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

NCT ID: NCT01776060

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-09-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Progressive Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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generation of 'omic markers of disease progression

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Gr, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Medicine Site Based Research Group

Locations

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NE Neurology

Concord, North Carolina, United States

Site Status

The Stedman Center on the Duke Center for Living Campus

Durham, North Carolina, United States

Site Status

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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Pro00040961

Identifier Type: -

Identifier Source: org_study_id

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